TECHNICAL DOCUMENT
European surveillance of
Clostridium difficile infections
Surveillance protocol version 2.3
www.ecdc.europa.eu
ECDC TECHNICAL DOCUMENT
European surveillance of
Clostridium difficile infections
Surveillance protocol version 2.3
This technical document is an update of ‘European Surveillance of Clostridium difficile infections. Surveillance
protocol version 2.2’. A draft of protocol version 2.1 was sent for consultation to the ECDC National Focal Points
(NFPs) for Healthcare-Associated Infections (HAIs) and to the ECDC Advisory Forum, and was published by ECDC
on 5 May 2015. An updated protocol (version 2.2) was sent to NFPs for HAIs for comments in October 2015 and
published on 17 November 2015. The current protocol (version 2.3) was prepared by Pete Kinross and Carl
Suetens.
Acknowledgements
ECDC would like to thank the contributing authors for a previous version of this protocol (version 2.1): Axel Kola,
Michael Behnke, Petra Gastmeier (Charité - Universitätsmedizin Berlin, Germany); Sofie M van Dorp, Ed J Kuijper
(Leiden University Medical Center, The Netherlands); and other members of the ECDIS-Net project surveillance
working group for contributing to the CDI protocol meetings (Berlin, 27 Feb 2012; Berlin (ECCMID), 27 Apr 2013;
Leiden, 22 Jan 2014), organising the pilot surveillance study in 2013 and/or commenting on protocol version 2.1: D
Schmid, E Simons, F Allerberger (Austria); J van Broeck, M Delmée (Belgium); V Jindrák (Czech Republic); K EP
Olsen (Denmark), A Pavelkovich, M Altmets (Estonia), O Lyytikäinen, S Mentula (Finland), F Barbut, A Collignon, B
Coignard, S Vaux, K Chami (France), D Weitzel-Kage (Germany), A Hajdu, A Kurcz, K Borocz, K Antmann, Zs Barna
(Hungary), A Ingebretsen, E Lingaas (Norway), D Notermans, S C de Greef, B van Benthem (the Netherlands), H
Pituch, P Karpinski (Poland), I S Macovei (Romania), M Drakulovic, M Jovanovic (Serbia), T Åkerlund, J Struwe
(Sweden), C Wiuff, J Coia, T Morris, M Wilcox (United Kingdom), Hospital Contact Points of the pilot CDI
surveillance study. Declarations of interest were received from the contractors of the ECDIS-Net project, in
accordance with ECDC’s Independence Policy, and no conflict was identified.
ECDC would also like to thank the nationally-designated attendees of the meeting ‘Workshop and meeting on
epidemiological surveillance of Clostridium difficile infections (HAI-Net CDI)’ at ECDC on 14 September 2016, for
their comments on potential updates to version 2.2 of this protocol: D Schmid (Austria); P Verroens (Belgium); E
Dobreva (Bulgaria); A Budimir (Croatia); V Jindrák (Czech Republic); B Kristensen (Denmark); P Märtin (Estonia);
O Lyytikäinen (Finland); F L’Hériteau (France); F Barbut (France); B Weiss (Germany); F Maechler (Germany); Á
Hajdu (Hungary); A Elfarsdottir (Iceland); S Hennessy (Ireland); F Fitzpatrick (Ireland); E Ricchizzi (Italy); G Vizujė
(Lithuania); M Debacker (Luxembourg); E Scicluna (Malta); E Astrup (Norway); O Kacelnik (Norway); H Pituch
(Poland); PA Raposo Assunçâo Fernandes (Portugal); A Niculcea (Romania); S Litvová (Slovakia); J Kolman
(Slovenia); A Asensio (Spain); P Gallego Berciano (Spain); EM Terveer (the Netherlands); EJ Kuijper (the
Netherlands); R Hope (United Kingdom); C Wiuff (United Kingdom); M Morgan (United Kingdom).
Suggested citation: European Centre for Disease Prevention and Control. European Surveillance of Clostridium
difficile infections. Surveillance protocol version 2.3. Stockholm: ECDC; 2017.
Stockholm, April 2017
ISBN 978-92-9498-056-4
doi 10.2900/021745
Catalogue number TQ-01-17-382-EN-N
© European Centre for Disease Prevention and Control, 2017
Reproduction is authorised, provided the source is acknowledged
ii
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TECHNICAL DOCUMENT
European surveillance of Clostridium difficile infections – surveillance protocol version 2.3
Contents
Abbreviations ............................................................................................................................................... iv
Background ................................................................................................................................................... 1
Objectives ..................................................................................................................................................... 1
Objectives of CDI surveillance in the EU ...................................................................................................... 1
Objectives of this protocol ......................................................................................................................... 1
Differences between protocol versions 2.1 and 2.2 ...................................................................................... 2
Differences between protocol versions 2.2 and 2.3 ...................................................................................... 2
Definitions and inclusion/exclusion criteria ........................................................................................................ 3
Acute care Hospitals.................................................................................................................................. 3
Long-term care facility .............................................................................................................................. 3
Healthcare facility ..................................................................................................................................... 3
Community .............................................................................................................................................. 3
Wards ...................................................................................................................................................... 4
Patient (denominator) data ........................................................................................................................ 4
Definition of Clostridium difficile infection (CDI) ........................................................................................... 4
Case (numerator) data .............................................................................................................................. 4
New episode of CDI .................................................................................................................................. 4
Recurrent CDI cases ................................................................................................................................. 4
CDI case origin ......................................................................................................................................... 5
Data collection: the three options .................................................................................................................... 6
Who collects the data? .............................................................................................................................. 6
Form H: Hospital-based data ........................................................................................................................... 7
Definitions ................................................................................................................................................ 7
Form C: Case-based data ............................................................................................................................. 10
Definitions .............................................................................................................................................. 10
Form M: Isolate shipment data sheet ............................................................................................................. 15
Definitions .............................................................................................................................................. 15
References .................................................................................................................................................. 17
Annex 1. Specialty code list........................................................................................................................... 18
Annex 2. Other hospital variables that must be added at national level before submission to The European
Surveillance System (TESSy) ......................................................................................................................... 19
Figures
Figure 1. Designation of CDI cases as healthcare-associated or community-associated based on location and time
of onset of symptoms. .................................................................................................................................... 5
Tables
Table 1. Collection of information for different surveillance options ..................................................................... 6
Table 2. Definitions of hospital types ............................................................................................................... 7
Table 3. McCabe score categories for classification of underlying medical conditions .......................................... 11
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TECHNICAL DOCUMENT
Abbreviations
AHG
Administrative Hospital Group
APACHE
Acute Physiology and Chronic Health Evaluation
ARHAI
Antimicrobial resistance and healthcare-associated infections
CA CDI
Community-associated Clostridium difficile infection
CDI
Clostridium difficile infection (previously also referred to as C. difficile associated diarrhoea (CDAD)
ESCMID
European Society of Clinical Microbiology and Infectious Diseases
ECDIS-Net
European Clostridium difficile Infection Network project
ESGCD
ESCMID Study Group for Clostridium difficile
EIA
Enzyme immunoassay
GDH
Glutamate dehydrogenase
HA CDI
Healthcare-associated Clostridium difficile infection
ICU
Intensive care unit
LTCF
Long-term care facility
MIC
Minimum inhibitory concentration
NAAT
Nucleic acid amplification test
NFP
National Focal Point
PCR
Polymerase chain reaction
TcdA
Clostridium difficile toxin A
TcdB
Clostridium difficile toxin B
Toxin A/B EIA Enzyme immunoassay for both toxins A and B
UNK
Unknown
iv
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TECHNICAL DOCUMENT
European surveillance of Clostridium difficile infections – surveillance protocol version 2.3
Background
In response to the emerging problems with Clostridium difficile infections (CDIs), the European Centre for Disease
Prevention and Control (ECDC) in collaboration with the US Centres for Disease Control and Prevention (CDC),
published background information about the changing epidemiology of CDIs, agreed on CDI case-definitions and
issued recommendations for the surveillance of CDIs
[1]. An ECDC-funded survey performed in 2008
[2] revealed a
mean incidence of 4.1 per 10 000 patient-days per hospital (range: 0.0–36.3), almost 70% higher than that
reported in a previous European surveillance study
[3] performed in 2005 (2.45 per 10 000 patient-days per
hospital, range: 0.13–7.1), although each survey had a different design. Standardised periodic or continuous
surveillance of the incidence of CDI is more likely to facilitate the identification of epidemiological changes and is
an essential tool for CDI prevention and control [4,5]. Microbiological data may be an important supplement to
surveillance data and allow further insights into epidemiological changes.
Facing the lack of standardised surveillance of CDI in EU Member States, ECDC launched a call for tender to
support capacity building for surveillance of Clostridium difficile infections at the European level in 2010. The
contract was awarded to a consortium that carried out the European Clostridium difficile Surveillance Network
(ECDIS-Net) project from 20 December 2010 to 30 November 2014i. The ECDIS-Net project developed a protocol
for the surveillance of CDI, which was piloted in 37 hospitals in 14 countries in 2013 [6]. The current protocol
incorporates feedback from countries and hospitals that participated in the pilot survey, feedback from the final
meeting of the ECDIS-Net project, as well as discussion with the ESCMID Study Group for C. difficile (ESCGD) to
obtain information about its draft and final versions of the ‘ESCMID guideline: update of the diagnostic guidance
document for Clostridium difficile infection’ [7,8].
Objectives
Objectives of CDI surveillance in the EU
The objectives for the surveillance of CDIs are:
to estimate the incidence of CDIs in European acute care hospitals;
to assess the burden of CDIs (including recurrent CDI cases) in European acute care hospitals;
to provide participating hospitals with a standardised tool to measure and monitor their own incidence
rates, and to compare incidence rates with those observed in other participating hospitals;
to assess adverse outcomes of CDIs including death;
to describe the epidemiology of C. difficile at the local, national and European level, in terms of factors such
as antibiotic susceptibility, PCR ribotype, presence of Clostridium difficile toxin A (TcdA), Clostridium difficile
toxin B (TcdB) and binary toxin, morbidity and mortality of infection, and the detection of new/emerging
types;
to promote use of CDI diagnostic practices that have a high diagnostic accuracy.
Objectives of this protocol
This protocol prescribes the methodology, and provides the data collection tools required to achieve the objectives
of European surveillance of CDIs. This requires national or regional coordinators to choose one of three CDI
surveillance options for data collection by data collectors at the hospital level. Each option corresponds to the
collection of progressively more detailed information:
the minimal CDI surveillance option corresponds to collection of only aggregated numerator and
denominator data;
the light surveillance option necessitates collection of case-based numerator data and aggregated
denominator data;
the enhanced surveillance option necessitates collection of microbiological data, i.e. molecular
characterisation and antimicrobial susceptibility testing data, for the isolates corresponding to the first 5
consecutively detected CDI cases in each healthcare facility (see section ‘Data collection’).
i Consortium composed of Leiden University Medical Center, the Netherlands (E.J. Kuijper, coordination), University of Leeds and
the Health Protection Agency, England, United Kingdom (M. Wilcox), University Hospital of Wales, Cardiff, United Kingdom (V.
Hall), Centre for Infectious Disease Control, RIVM, Bilthoven, the Netherlands (D. Notermans), Charité - Universitätsmedizin
Berlin, Germany (P. Gastmeier, A. Kola), in col aboration with ECDC (C. Suetens, K. Weist, P. Kinross).
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TECHNICAL DOCUMENT
Data collected using these forms should, in each Member State, be sent to the country institution designated by
the country’s Coordinating Competent Bodyi. These institutions are then requested to upload the data to the
European Surveillance System (TESSy) at ECDC, according to the same methodology used for other communicable
diseases and related special health issues within Decision 1082/2013/EUii, i.e. verifying that patient identifiers are
not included and adding information for the variables listed in Annex 2.
Differences between protocol versions 2.1 and 2.2
Protocol version 2.1 is no longer valid. It has been superseded by version 2.2 and version 2.3.
Form E has been removed. It was used in the enhanced surveillance option to collect additional case-based
data. Its variables have been incorporated into Form C (i.e. for the light surveillance option) and labelled as
‘optional’ with the exception of ‘Ward speciality’.
On Form C, ‘Ward speciality’ has been simplified to 12 categories, to match the other ECDC surveillance
modules, including the ECDC point prevalence survey of healthcare-associated infections (HAIs) and
antimicrobial use in European acute care hospitals (see Annex 1).
On Form C, ‘Consultant/Patient speciality’ has been added; the variable contains a larger number of
categories than ‘Ward speciality’ (see Annex 1).
On Form H, the options for ‘Algorithms used for CDI diagnosis’ have been updated incorporating the
November 2015 update of the ESCMID diagnostic guidance document for CDI [5].
In the previous protocol (version 2.1), algorithms were categorised in three categories with
decreasing order of expected diagnostic accuracy. The current protocol (version 2.2) only has two
groups: ‘ESCMID-recommended’ and ‘Other’.
Eight of the original 12 listed diagnostic algorithms are unchanged, including the category ‘Other,
please specify…’
One algorithm has been deleted, i.e. ‘Multiple methods for the same stool specimen’, as these can be
reported within ‘Other, please specify…’
Two algorithms have been amalgamated, resulting in the second algorithm within the category
‘ESCMID-recommended’, i.e. ‘Screening with both GDH and toxin A/B EIA, optional confirmation with
NAAT or toxigenic culture’.
One algorithm is new, listed within the category ‘ESCMID-recommended’, i.e. ‘Screening with GDH
EIA, confirmation with toxin A/B EIA, optionally second confirmation with NAAT or toxigenic culture’.
Other minor language and format edits.
Differences between protocol versions 2.2 and 2.3
ECDC recommends use of protocol version 2.3. Protocol version 2.2 is still valid, even though it does not contain
the updates and clarifications in protocol version 2.3 that are described in this section.
In the section ‘Definitions and inclusion/exclusion criteria’:
Addition of definitions for healthcare facility (particularly the requirement for an overnight stay),
community and ‘new episode of CDI’.
Clarifications to current definitions, including CDI case origin and recurrent cases. In particular, the
definition of healthcare-associated CDI now includes explicit text advising inclusion of cases who
were discharged from a healthcare facility within the past four weeks and had onset of symptoms on
the day of admission or on the following day.
On Form H:
Addition of variables for whether the participating hospital is part of an administrative hospital group
(also referred to as ‘trusts’, ‘mergers’, ‘fusions’, ‘boards’, ‘chains’, etc.). These match variables used
in other ECDC HAI-Net surveillance systems, e.g. the ECDC point prevalence survey (PPS) of HAIs
and antimicrobial use in European acute care hospitals.
Clarification of definitions of variables, particularly CDI case origin (see changes to ‘Definitions and
inclusion/exclusion criteria’).
Addition of the text ‘do include cases that have an unknown recurrence status’ to the definitions of
‘number of healthcare-associated CDI (HA CDI) cases’ and ‘number of Community-associated CDI
(CA CDI) cases and CDI cases of unknown origin’.
Clarification of the categories of algorithms for CDI diagnosis that are suitable to align with current
ESGCD guidance [7].
i European Centre for Disease Prevention and Control. Information on the Competent Bodies.
http://ecdc.europa.eu/en/aboutus/Competent%20bodies/Pages/Competent_bodies.aspx
ii Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to
health and repealing Decision No 2119/98/EC
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European surveillance of Clostridium difficile infections – surveillance protocol version 2.3
On Form C:
Addition of the variable ‘Reason for typing’.
Addition of a subcategory to ‘previous healthcare admission (optional)’ to indicate previous admission
to both hospital(s) and long-term care facilities (LTCFs).
Removal of the subcategory ‘Other healthcare facility with overnight stay’ as the ‘CDI case origin’ for
HA CDI because the subcategory is redundant.
Clarification of definitions of variables, particularly CDI case origin (see changes to ‘Definitions and
inclusion/exclusion criteria’). Other clarifications to definitions include ‘Ward/unit ID’, ‘complicated
course of CDI’ and ‘date of discharge/in-hospital death’
The definition of HA CDI now contains a prioritisation algorithm to help data collectors assign the
‘origin of the infection’ for cases with multiple recent healthcare contacts.
Simplification of the variable ‘Ward/unit speciality’ through provision of a shorter list of specialties
(see Annex 1).
On Form M:
The title has been changed from ‘isolate shipment data sheet’ to ‘isolate data sheet’.
Minimum participation in the enhanced surveillance option has been reduced to: isolates from 5
consecutive patients per surveillance period per hospital. There is no maximum defined in this
protocol. Hospitals that participate in the enhanced surveillance option and have fewer than 5 cases
per surveillance period should collect data on all these cases. Protocol version 2.2 requested
collection of 10 sequential isolates.
Other format edits (e.g. Annex 1) and language edits. Addition of references 4 – 8.
Definitions and inclusion/exclusion criteria
This section provides definitions and inclusion/exclusion criteria for reference. It is recommended that they are
read before surveillance activities. The definition of each variable collected using a surveillance form is provided
within the section of this protocol dedicated to that particular form.
Acute care Hospitals
An objective of this CDI surveillance protocol is to estimate the incidence of CDIs in European acute care hospitals.
An acute care hospital is defined according to national definitions.
All acute care hospitals are eligible for
inclusion. There is no minimum size of hospitals.
It is preferable for hospitals with more than one geographical site to report each site that has a separate infection
control team/unit separately, if this is feasible. Otherwise, it is sufficient to report for the entire hospital group.
The participation of hospitals to the national surveillance of CDI may be voluntary or mandatory, depending on the
country. Representative sampling of hospitals is not required but is recommended.
Long-term care facility
A long-term care facility (LTCF) is defined as a facility in which residents need constant supervision (24 hours);
need ‘high-skilled nursing care’ (i.e. more than ‘basic’ nursing care and assistance for daily living); are medically
stable and do not need constant ‘specialised medical care’ (i.e. administered by specialised physicians); and do not
need invasive medical procedures (e.g. ventilation). Examples include, but are not limited to, nursing homes,
residential homes and mixed long-term care facilities.
Healthcare facility
For the purposes of establishing ‘CDI case origin’ and facilitating data collection regarding a ‘previous healthcare
admission’, a healthcare facility is defined as a facility that provides services for patients (or residents) that require
an overnight stay, i.e. ‘acute and chronic care hospitals and long-term care facilities’.
The following locations should be excluded: outpatient and other ambulatory care centres, hostel care (hotel
without any kind of nursing care), sheltered care houses, day centres, home-based centres, protected living or any
other healthcare facility where patients (or residents)
do not stay overnight.
Community
The community is considered to be all locations that are not healthcare facilities as defined above.
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Wards
Include all wards in acute care hospitals, including long-term care wards. Exclusion of wards is not allowed.
Patient (denominator) data
All hospitalised patients should be included in the denominator, including children age two years or less. A patient
is considered as hospitalised when he or she is registered as such in the local hospital administration system and
will therefore contribute to the denominator data (number of admissions or discharges, number of patient-days).
Usually, this involves at least one overnight stay in the hospital.
A bed-day is a day during which a person is confined to a bed and in which the patient stays overnight in a
healthcare facility. Day cases (patients admitted for a medical procedure or surgery in the morning and released
before the evening) should be excluded. (Source:
http://stats.oecd.org/glossary/detail.asp?ID=194)
Definition of Clostridium difficile infection (CDI)
A case of Clostridium difficile infection (CDI) (previously also referred to as C. difficile-associated diarrhoea or
CDAD) must meet at least one of the following criteria [1]:
diarrhoeal stools or toxic megacolon AND a positive laboratory assay for C. difficile toxin A and/or B in stools
or a toxin-producing C. difficile organism detected in stool via culture or other means e.g. a positive PCR
result;
OR
pseudomembranous colitis revealed by lower gastro-intestinal endoscopy;
OR
colonic histopathology characteristic of C. difficile infection (with or without diarrhoea) on a specimen
obtained during endoscopy, colectomy or autopsy.
Case (numerator) data
Numerator data are collected for all hospitalised patients that meet the definition of CDI, and meet
at least one of
the following inclusion criteria.
Inclusion criteria:
the date of CDI symptom onset was within the surveillance period (even if the patient was admitted before
the start of the surveillance period);
OR
the patient was admitted to the hospital during the surveillance period with signs and symptoms of CDI
present at admission, even if this episode of CDI was already diagnosed prior to admission (e.g. at the
outpatient department);
OR
recurrent cases of CDI (see definition below).
Exclusion criteria:
day cases, e.g. one day surgery; patients in the emergency room; dialysis patients (outpatients).
It is recognised that many children are asymptomatically colonised with C. difficile. Detection of C. difficile in
children of less than two years of age should only lead to the inclusion of these patients as CDI cases in the
numerator if there is compelling clinical evidence for CDI.
New episode of CDI
A new episode is defined as symptoms of CDI with a positive laboratory test more than two weeks after the onset
of any symptoms of CDI.
Recurrent CDI cases
In clinical practice, it is not possible to differentiate between a relapse involving the same strain and re-infection
with a different strain. The term ‘recurrence’ is used as a designation for both.
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European surveillance of Clostridium difficile infections – surveillance protocol version 2.3
Recurrent CDI cases are patients meeting the CDI case definition with an episode of CDI (return of diarrhoeal
stools with a positive laboratory test after the end of treatment) more than two weeks and less than eight weeks
following the onset of a previous episode (no matter where that previous episode occurred).
CDI cases with symptom onset more than eight weeks after the onset of a previous episode are included as new
CDI cases. When evaluating the time window, the date of the return of the CDI symptoms should be considered.
Only consider the date of sampling if the date of onset of symptoms is unknown.
CDI case origin
The origin of a CDI case can be healthcare-associated, community-associated or unknown (Figure 1).
Figure 1. Designation of CDI cases as healthcare-associated or community-associated based on
location and time of onset of symptoms.
Source: [1]. In practice, for this protocol, ‘48h’ is interpreted as on the day of admission or on the fol owing day.
Healthcare-associated CDI (HA CDI) is defined as a case of CDI with onset of symptoms:
on day three or later, following admission to a healthcare facility on day one,
OR
in the community within four weeks of discharge from a healthcare facility (including the current hospital or
a previous stay in any other healthcare facility).
Community-associated CDI (CA CDI) is defined as a case of CDI with onset of symptoms:
outside of healthcare facilities
AND without discharge from a healthcare facility within the previous 12 weeks,
OR
on the day of admission to a healthcare facility or on the following day
AND not resident in a healthcare facility within the previous 12 weeks.
Unknown association:
the CDI case was discharged from a healthcare facility 4–12 weeks before the onset of
symptoms.
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Data collection: the three options
Data are collected following either the ‘minimal’, the ‘light’ or the ‘enhanced’ CDI surveillance option. As shown in
Table 1, the ‘minimal’ surveillance option requires collecting information with only Form H, the ‘light’ surveillance
option requires collecting information with Form H and Form C, and the ‘enhanced’ surveillance option requires
collecting information with Forms H and C as well as Form M.
If a hospital has zero cases within a surveillance period, it should still complete Form H as this form is used to
collect valuable denominator data.
Table 1. Information collected for different CDI surveillance options
Minimal surveillance
Light surveillance
Enhanced surveillance
Form
Minimum CDI
Minimum CDI
Minimum CDI
Form H
surveillance for each
surveillance for each
surveillance for each
(aggregated
hospital
hospital
hospital
numerator and
(aggregated numerator
(aggregated numerator
(aggregated numerator
denominator data)
data)
data)
data)
Hospital data for each
Hospital data for each
Hospital data for each
n
hospital
hospital
hospital
(aggregated denominator
(aggregated denominator
(aggregated denominator
data)
data)
data)
rmatio
o
Information on each
Information on each
Form C
CDI case
CDI case
(case-based
inf
d
(case-based numerator
(case-based numerator
numerator data)
data)
data)
llecte
Microbiological data
Form M
o
(for the first 5
(one form for each C.
C
consecutively detected
difficile isolate)
cases in each
participating healthcare
facility: characterisation,
susceptibility testing and
typing of each C. difficile
isolate)
Recommended: continuous surveil ance for 12 months, starting on the first* day of the month.
d
o
The recommended
minimum surveil ance period is three consecutive months, preferably from 1 October to 31 December,
or from 1 January to 31 March.
e peri
Note that on average, a 300-bed European hospital (with 100% bed occupancy) can expect seven CDI cases every
eillanc
three months, or 28 cases per year, for an incidence of three CDI cases per 10 000 patient-days.
urv
S
*The pilot study demonstrated that completion of Form H is made much easier by starting surveil ance on the first day
of a month.
Who collects the data?
The composition of the team responsible for data collection may vary from one hospital to another. It is
recommended that hospital infection control personnel as well as the team in charge of the patients are both
involved. It is likely that most hospitals using the enhanced surveillance module will acquire microbiological data
(Form M) from clinical microbiology laboratory personnel.
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Form H: Hospital-based data
This form is used to collect denominator data in the minimal, light and enhanced surveillance options.
The minimum requirement for CDI surveillance is completion of Form H alone.
Hospital-based aggregated denominator data are collected for all eligible patients within a participating hospital.
Participating hospitals with no case during a surveillance period should still complete Form H as it is used to collect
valuable denominator data. One Form H should be filled out for each surveillance period. The recommended
minimum surveillance period is three consecutive months, from 1 October to 31 December, or from 1 January to
31 March.
In addition to the denominator data, the following aggregated data are collected for each surveillance period at the
hospital level:
Basic hospital characteristics: hospital type and size, necessary for stratification of incidence rates;
Aggregated numerator data: together with the denominator data, these data allow the calculation of the
incidence of healthcare-associated (and total) CDI in participating hospitals, and therefore correspond to
the minimal data set for CDI surveillance. The number of cases reported on this form should correspond to
the number of completed case files in the light surveillance option;
Frequency of testing for CDI and diagnostic tests in use: process indicator of surveillance sensitivity.
If a hospital has several facilities located on different sites, data should be only merged for those sites which are
related in terms of infection control.
Definitions
Hospital code (required): hospital identifier/code is assigned by the national/regional CDI surveillance
coordinator. Hospital codes should be unique within each surveillance network, and kept constant between the
ECDC Antimicrobial Resistance and Healthcare-Associated Infection (ARHAI) surveillance protocols and from one
year to the next.
Hospital type (required): designate
the hospital as being Primary, Secondary, Tertiary or Specialised, using
Table 2 as a guide. If the hospital is ‘Specialised’, please specify the specialisation (e.g. paediatric hospital,
infectious diseases hospital), after having consulted the categories of speciality listed in the Annex 1.
Table 2. Definitions of hospital types
Primary
Few specialities (mainly internal medicine, obstetrics-gynaecology, paediatrics, general surgery or only general
practice).
Limited laboratory services are available for general, but not for specialised pathological analysis.
Often corresponds to a general hospital without teaching function.
Secondary Often referred to as a ‘provincial hospital’.
Hospital is highly differentiated by function with five to ten clinical specialities, such as haematology, oncology,
nephrology, ICU.
Takes some referrals from other (primary) hospitals.
Often corresponds to a general hospital with teaching function.
Tertiary
Often referred to as a ‘central’, ‘regional’ or ‘tertiary-level’ hospital.
Highly specialised staff and technical equipment (ICU, haematology, transplantation, cardio-thoracic surgery,
neurosurgery); specialised imaging units.
Clinical services are highly differentiated by function.
Provides regional services and regularly takes referrals from other (primary and secondary) hospitals.
Often a university hospital or associated with a university.
Specialised Single clinical specialty, possibly with sub-specialties.
Highly specialised staff and technical equipment.
Hospital type. Free text. Include hospital specialty if specialised hospital (e.g. paediatric, infectious diseases,
etc.). If possible, please use the specialty codes listed in Annex 1, e.g. PED=Paediatrics.
Hospital is part of administrative hospital group (AHG): Yes/No. The hospital is part of an administrative
group of hospitals (AHG, including entities referred to as ‘trusts’, ‘mergers’, ‘fusions’, ‘boards’, ‘chains’, etc.).
Data apply to single hospital site or to AHG/trust. If the hospital is part of an administrative hospital group
(AHG), specify if the data in Form H apply to a single hospital (i.e. a hospital with a single address, or a hospital
site within an AHG) (S); or to the entire AHG (T).
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TECHNICAL DOCUMENT
AHG code. Free text, selected and generated by countries. Unique code/identifier for the AHG. Please ensure that
the AHG code/identifier is identical for all hospital sites belonging to that AHG, if applicable. The code should
remain identical in different surveillance periods and years. It can be identical to the hospital code if the data apply
to the AHG.
AHG type. Primary/Secondary/Tertiary/Specialised (see definition of ‘Hospital type’ above). If the hospital is part
of an AHG, specify the ‘hospital type’ of the entire AHG. Report the highest level of specialisation for the AHG, e.g.
‘TERT’ if a group with four sites contains one specialised, one primary, one secondary and one tertiary hospital.
Note that the combined services of an AHG may increase the overall level of specialisation, above any one hospital
within the AHG, i.e. the combination of clinical specialties provided by primary and/or specialised hospitals may
result in the AHG matching the definition of a secondary hospital).
Surveillance period (required for each surveillance period): start and end date for the CDI surveillance
period.
Exclusion of Wards/Units (required): All wards/units should be included for the surveillance of CDI. If, despite
this recommendation certain wards/units were excluded, it is crucial that the aggregated denominator data are
provided for the included wards/units only.
Number of beds (required): number of hospital beds for the current surveillance period. All wards should be
included for the surveillance of CDI, exclusion of wards is not allowed.
Number of discharges or admissions (required): number of hospital discharges in the current surveillance
period. Use number of admissions if discharges are not available.
Number of patient-days (required): number of hospital patient-days in the current surveillance period.
Number of HA CDI cases (required): number of healthcare-associated CDI cases within the surveillance period
(i.e. with onset on day three or later, following admission to a healthcare facility on day one, OR in the community
within four weeks of discharge from any healthcare facility). Exclude recurrent cases. Do include cases that have
an unknown recurrence status.
Number of CA CDI cases and CDI cases of unknown origin (required): number of community-associated
CDI cases and cases of unknown origin within the surveillance period i.e. include cases with onset outside of
healthcare facilities, AND without discharge from a healthcare facility within the previous 12 weeks, OR onset on
the day of admission to a healthcare facility or on the following day AND not resident in a healthcare facility within
the previous 12 weeks, OR a CDI case discharged from a healthcare facility 4–12 weeks before the onset, OR
cases for which the origin is unknown. Exclude recurrent cases. Do include cases that have an unknown recurrence
status.
Number of recurrent CDI cases: number of CDI episodes with onset within two and eight weeks of a previous
episode (including both healthcare-associated and community-associated recurrent cases).
Number of stool specimens tested: number of stool specimens tested for CDI in the surveillance period. Each
specimen should only be counted once, even if more than one test was performed on that specimen. Count the
number of stool specimens actually processed by the laboratory (= at least one test for CDI was performed on the
sample), not the number sent to the laboratory for analysis.
Number of stool specimens that tested positive for CDI: number of stools tested for CDI with a positive test
result in the surveillance period. Each specimen should only be counted once.
Algorithm used for CDI diagnosis: laboratory test(s) applied on faeces samples to recognise the presence of
toxin-producing C. difficile, either as a solitary test or as a combination of screening and confirmatory tests. If no
algorithms match your algorithm, indicate the algorithm which matches most closely. If multiple algorithms are
applied (i.e. depending on work hours or patient categories), please indicate the most frequently applied
algorithm(s), that is/are used for more than 80% of the samples tested for C. difficile.
Toxin A/B EIA
Enzyme immunoassays, including enzyme-linked immunosorbent assays (ELISA), that test
for both toxins A and B in stool samples or cultures.
GDH EIA
Enzyme immunoassays, including enzyme-linked immunosorbent assays (ELISA), that test
for both Glutamate dehydrogenase in stool samples or cultures.
NAAT
Nucleic acid amplification tests (e.g. polymerase chain reaction, PCR).
Cytotoxicity assay Demonstration that stool sample supernatant kills a cell monolayer in the absence of a C.
difficile toxin-neutralising antibody.
Toxigenic culture
Demonstration that a C. difficile culture is able to produce toxins in vitro, e.g. by
cytotoxicity assays, Toxin A/B EIA or NAAT from colonies.
Toxin detection
Detection of toxins, in stool samples or cultures, e.g. by toxin A/B EIA or cell cytotoxicity
assays.
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European surveillance of Clostridium difficile infections – surveillance protocol version 2.3
European surveillance of Clostridium difficile infections
Form H: Hospital-based data (all types of surveillance)
Hospital code: __________
Hospital type:
Primary
Secondary
Tertiary
Specialised (please specify: _______________)
Hospital is part of administrative hospital group (AHG):
No
Yes
If yes: Data apply to: Hospital site only
All hospitals in AHG
AHG type:
Primary
Secondary
Tertiary
Specialised
Surveillance period: From ___ / ___ / 20___ (dd/mm/yyyy)
to ___ / ___ / 20___ (dd/mm/yyyy)
For the above surveillance period, for this hospital, please specify:
Attribute
Number
No. of beds
No. of discharges (or admissions)
No. of patient-days
No. of HA1,3 CDI cases
No. of CA2,3 CDI cases or CDI cases of unknown origin
No. of recurrent CDI cases
No. of stool specimens tested for CDI
No. of stool specimens that tested positive for CDI
1HA: healthcare-associated; 2CA: community-associated, 3recurrent cases excluded
Exclusion of wards/units: No (recommended)
Yes (not recommended)
If some wards/units were excluded, specify which wards/units were excluded:
______________________________________________________________________________________________
Important: All wards/units should be included for the surveillance of CDI. If, despite this recommendation certain
wards/units were excluded, it is crucial that the aggregated denominator data are provided for the included
wards/units only.
Algorithm used for CDI diagnosis: The diagnostic algorithms below are categorised in decreasing order of
expected diagnostic accuracy (maximised sensitivity and specificity). If no algorithm is adequate, indicate the test
algorithm which is the closest to the one that you apply. If you apply multiple algorithms, please indicate the most
frequently applied algorithm(s), that is/are used for >80% of the samples tested for C. difficile.
ESCMID-recommended [5]*:
Screening with NAAT, confirmation with toxin A/B EIA
Screening with both GDH and toxin A/B EIA, optional confirmation with NAAT or toxigenic culture
Screening with GDH EIA, confirmation with toxin A/B EIA, optionally second confirmation with NAAT or
toxigenic culture
Other:
Screening with GDH, confirmation with NAAT
Screening with GDH, confirmation with toxigenic culture
NAAT alone
Screening with toxin detection, confirmation with NAAT or toxigenic culture
Toxigenic culture alone
EIA for toxins alone
Stool cytotoxicity assay alone
Other, please specify: ____________________
* Crobach MJT, Planche T, Eckert C, et al., European Society of Clinical Microbiology and Infectious Diseases: update of the
diagnostic guidance document for Clostridium difficile infection, Clin Microbiol Infect. 2016 Aug;22 Suppl 4:S63-81. Doi
10.1016/j.cmi.2016.03.010. Epub 2016 Jul 25:
http://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(16)30025-8/ful text
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Form C: Case-based data
This form is used to collect case-based numerator data in the light and enhanced surveillance options. Numerator
data are collected for all hospitalised patients that meet the CDI case definition and inclusion criteria (see above),
including both those with symptoms at admission and those who developed symptoms after admission.
Definitions
Hospital code (required): hospital identifier/code is assigned by the national/regional CDI surveillance
coordinator. Hospital codes should be unique within each surveillance network and kept constant between ECDC
ARHAI surveillance protocols and from one year to the next.
Surveillance period (required): start and end date for the surveillance in the entire hospital. This will be linked
with the denominator data.
Patient counter (required): provide an anonymised patient number. In enhanced surveillance, this number
should permit linkage of patient data with microbiological typing/susceptibility data and patient data from
enhanced surveillance. Patient identifiers must not be used.
Sex: gender of the patient: M (male), F (female).
Age in years: patient age in years; if missing=unknown (UNK). Provide the patient’s age in months if the patient
is less than two years old.
Previous healthcare admission (optional): previous admission to a healthcare facility in the last three months
relative to the onset of CDI: Yes/No/Unknown. If yes, was the case admitted (a) to a hospital or another
healthcare facility e.g. LTCF, or (b) to both LTCF and hospital, or (c) to other/unspecified type(s) of healthcare
facility. Collect these data from electronic records and/or patient notes, and/or by asking the patient.
Date of hospital admission (required): date patient was admitted to the hospital for the current hospitalisation
(dd/mm/yyyy).
Ward/unit ID: abbreviated name of hospital ward where the case is located currently; the abbreviated name
should be used consistently and should remain the same throughout different surveillance periods/years.
Ward/unit specialty (see code list): Main ward specialty (≥ 80% of patients requiring this specialty).
PED=Paediatrics, NEO=Neonatal, ICU=Intensive care, MED=Medicine, SUR=Surgery, GO=Gynaecology/Obstetrics,
GER=Geriatrics, PSY=Psychiatry, RHB=Rehabilitation, LTC=Long-term care, OTH=Other, MIX=Mixed. If fewer than
80%, report ‘mixed ward’ (MIX). See Annex 1.
Ward/unit name (optional): unique identifier for each ward/unit (abbreviated ward/unit name) within a
hospital; should remain unchanged throughout different surveillance periods/years.
Consultant/patient specialty (optional – see code list): please enter the code for the specialty of the
physician in charge of the patient; this may differ from the ward/unit specialty. See Annex 1 for the
consultant/patient specialty code list.
McCabe score (optional): Classification of the severity of underlying medical conditions. Disregard the influence
of an active CDI, i.e. estimate the score the patient had before the infection. Some examples of diseases and their
different McCabe score categories are given in Table 3. These examples, in particular those of the second
(ultimately fatal) category, are not meant to be exhaustive but rather serve as a guidance tool for the current
protocol.
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European surveillance of Clostridium difficile infections – surveillance protocol version 2.3
Table 3.
McCabe score categories for classification of underlying medical conditions
McCabe score categories
Examples
Rapidly fatal (< one year)
End-stage haematological malignancies (unsuitable for transplant, or relapsed), heart failure
(EF < 25%) and end-stage liver disease (unsuitable for transplant with recalcitrant ascites,
encephalopathy or varices)
Multiple organ failure on intensive care unit – APACHE II score > 30, SAPS II score >70
Pulmonary disease with cor pulmonale
Ultimately fatal: (one year
Chronic leukaemia’s, myelomas, lymphomas, metastatic carcinoma, end-stage kidney disease
to four years)
(without transplant)
Motor neuron disease, multiple sclerosis non-responsive to treatment
Alzheimer’s/dementia
Diabetes requiring amputation or post amputation
Non-fatal (> five years)
Diabetes
Carcinoma/haematological malignancy with > 80% five-year survival
Inflammatory disorders
Chronic GI, GU conditions
Obstetrics
Infections (including HIV, HCV, HBV – unless in above categories)
Al other diseases
EF: Ejection fraction, GI: Gastrointestinal , GU: Genitourinary, HCV: Hepatitis C virus, HBV: Hepatitis B virus
Symptoms of CDI present at admission (required): patient had CDI symptoms when admitted for this
episode, Yes/No/Unknown.
Date of onset of CDI symptoms: this is mandatory if symptom onset was during current hospitalisation, but not
recorded if signs/symptoms were present on admission. Record the date of the first signs or symptoms of the
infection (dd/mm/yyyy). If unknown, record the date treatment was started for this infection or the date the first
diagnostic sample was taken, whichever is first. If no treatment or sample, please estimate.
Date of first positive sample (optional): the date on which the first positive diagnostic stool sample was taken
from the patient referred to on this form.
Reason for typing (optional): as the enhanced surveillance option collects data from the first 5 samples during
a surveillance period, identify the rationale to type each sample, e.g. for routine surveillance activities; to
investigate an outbreak/potential cluster; because it was a severe case; etc.
Recurrent CDI (required): Yes/No/Unknown. Choose yes if the patient had an episode of CDI (return of
diarrhoeal stools with a positive laboratory test after the end of treatment) more than two weeks and less than
eight weeks following the onset of a previous episode.
When reporting recurrent cases, the ‘date of onset of CDI
symptoms’ should be for this recurrent episode rather than for a previous episode.
CDI case origin (required): Choose one (for detailed definitions, see Definitions section):
Healthcare-associated CDI: a case with onset of symptoms on day three or later, following admission to
a healthcare facility on day one, OR within four weeks of discharge from any healthcare facility. The origin
of the infection may have been the current hospital or another healthcare facility with overnight stay, e.g.
another hospital or a LTCF.
If the case had CDI on admission (or onset on the day of admission or the day following admission) and
exposure to multiple healthcare facilities during the last 4 weeks, if possible use this prioritisation algorithm
to associate the CDI to the healthcare facility with the highest risk of transmission/acquisition of C. difficile:
1.
Facility where the patient had a possible epidemiological link to another CDI case, e.g. shared a room
with CDI patient or hospitalised on a ward with a CDI outbreak (if multiple facilities, select the most
recent facility)
2. If no known possible epidemiological link to another CDI case:
i. Facility where the patient received treatment with high-risk antibiotics, e.g. clindamycin,
cephalosporins or fluoroquinolones (if multiple facilities, select the most recent one)
ii. Facility where the patient received treatment with lower-risk antibiotics, e.g. macrolides,
sulphonamides (if multiple facilities, select the most recent one)
3. If no known antimicrobial treatment: facility where the patient stayed the longest (if multiple facilities
with same length of stay in previous month or if length of stay is unknown, select the most recent
one)
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Community-associated CDI: a case with [onset outside of healthcare facilities, AND without discharge
from a healthcare facility within the previous 12 weeks*] OR [onset on the day of admission to a healthcare
facility or on the following day AND not resident in a healthcare facility within the previous 12 weeks]*
Unknown association: a case who was discharged from a healthcare facility* 4–12 weeks before
symptom onset
*note: only consider healthcare facility contacts with overnight stay
Complicated course of CDI (optional): Yes/No/Unknown. CDI leading to any of the following:
admission to a healthcare facility for treatment of community-onset CDI;
admission to an intensive care unit for treatment of CDI or its complications (e.g. for shock requiring
vasopressor therapy);
surgery (colectomy) for toxic megacolon, perforation or refractory colitis;
death within 30 days after onset if CDI is either a primary or contributing cause.
Patient outcome (required): status of the patient at hospital discharge or at end of follow-up in the hospital
Discharged alive: patient was discharged alive; OR patient was still in the hospital and alive at end of
follow-up during this hospital stay.
Death, CDI definitely contributed to death: use this category if a causal link between CDI and death
can be demonstrated.
Death, CDI possibly contributed to death: use this category if no causal link between CDI and this
case’s death can be demonstrated, but it is still plausible that CDI was at least a contributory factor.
Death, unrelated to CDI: use this category if the cause of death can be demonstrated not to be related
to CDI.
Death, relationship to CDI unknown: use this category if no evidence of contributory factors to the
cause of death is available.
Unknown: unknown patient outcome.
Date of discharge/in-hospital death: date the patient was discharged from the hospital; OR date of end of
follow-up if the patient was still hospitalised and alive; OR date of death if patient died during the current
hospitalisation. There is no requirement to ‘follow up’ patients beyond the end of the surveillance period. The
‘patient outcome’ of these patients meets the definition of ‘discharged alive’ (see above).
Microbiological data collected for this patient: Yes/No/Unkown. Indicate whether Form M has been
completed.
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European surveillance of Clostridium difficile infections – surveillance protocol version 2.3
European surveillance of Clostridium difficile infections.
Form C: Case-based data (light and enhanced surveillance)
Hospital code: __________________
Surveillance period: From ___ / ___ / 20___ (dd/mm/yyyy)
to ___ / ___ / 20___ (dd/mm/yyyy)
Patient counter: _______________________________________________________________
Internal patient code (optional)
: _________________________________________________
Sex: Male
Female
Age in years: ____; age if < 2 years old: ____ months.
Previous healthcare admission in the last 3 months (optional)
: (tick one)
Yes
No
Unknown
If yes, please specify: (tick one)
Hospital
Long-term care facility (LTCF)
LTCF(s) and hospital(s)
Other/not specified
Date of hospital admission: ___ / ___ / 20___ (dd/mm/yyyy)
Ward/unit ID (optional)
: _______________
Ward/unit specialty (optional; see code list): _______________
Ward/unit name (optional)
:__________________________
Patient/Consultant specialty (see code list): _______________
McCabe score (optional)
:
Non-fatal underlying disease (survival at least 5 years)
Ultimately fatal underlying disease (survival 1–4 years)
Rapidly fatal underlying disease (survival <1 year)
Unknown
Symptoms of CDI present at admission:
Yes
No
Unknown
Date of onset of CDI symptoms:__ / ___ / 20___ (dd/mm/yyyy)
Date of first positive sample (optional)
: ___ / ___ / 20___ (dd/mm/yyyy)
Reason typing requested (optional)
: (tick one)
Typing not requested
Surveillance
Investigation of outbreak/cluster
Severe case
Unknown
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European surveillance of Clostridium difficile infections.
Form C: Case-based data (light and enhanced surveillance) -
continued
Recurrent CDI (positive laboratory tests for CDI in diarrhoeal stools after the end of treatment for CDI occurring > 2
weeks and < 8 weeks following the onset of a previous episode):
Yes
No
Unknown
CDI case origin: (tick one)
Healthcare-associated (symptom onset on day three or later following admission to a healthcare facility on day
one, OR in the community within 4 weeks following discharge from any healthcare facility)
If yes, please specify the origin of the infection: (tick one)
Current hospital
Other hospital
Long-term care facility
Healthcare-associated, origin of the infection not specified
Community-associated (symptom onset [outside of healthcare facilities, AND without discharge from a healthcare
facility within the previous 12 weeks], OR [on the day of admission to a healthcare facility or on the following day
AND no residence in a healthcare facility within the previous 12 weeks])
Unknown association (including cases discharged from a healthcare facility 4–12 weeks before symptom onset)
Complicated course of CDI (optional)
:
e.g. admission to a healthcare facility for treatment of a community-onset CDI; CDI resulted in e.g. ICU admission, toxic
megacolon, surgery or death
Yes
No
Unknown
Patient outcome: (tick one)
Discharged alive
Death, CDI definitely contributed to death
Death, CDI possibly contributed to death
Death, no relation to CDI
Death, relationship to CDI unknown
Unknown
Date of hospital discharge/in-hospital death: ___ / ___ / ________(dd/mm/yyyy)
Microbiological data (Form M) collected for this patient:
Yes
No
Unknown
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Form M: Isolate shipment data sheet
This form is only used in the enhanced surveillance option.
If possible, stool samples from a minimum of 5 consecutive patients per hospital with primary or recurrent CDI that
tested positive for CDI should be stored at -20˚C and cultured for the presence of toxin-producing C. difficile using
the standard operating procedure for the culture and identification of C. difficile (available on request from ECDC),
or national or local protocols. Consider storing samples for all CDI cases, in case further diagnostic or typing tests
become available at a later date. Culture methods should be carried out under containment level 2 conditions using
the principle of ‘good laboratory practice’, or containment level 3 if Hazard Group 3 organisms are suspected to be
in the specimen.
C. difficile isolates should be sent for typing and characterisation to a laboratory designated at the national level by
the national coordinator, accompanied by a partially filled Form M. If typing and characterisation is not available at
the national level, support from a laboratory in another country should be sought. ECDC can be contacted for
suggestions.
Definitions
Network-Id: Unique identifier for each surveillance network within a Member State, selected and generated by
the Member State, e.g. for UK, EN, NI, SC or WA; for France, different CClin networks; this field is combined with
the hospital identifier to create a unique hospital code since different networks within one Member State may use
the same hospital code. Can be omitted if the hospital identifiers are unique within the reporting Member State.
Hospital code (required): hospital identifier/code assigned by national/regional CDI surveillance coordinator.
Hospital codes should be unique within each surveillance network and kept constant between ECDC ARHAI
surveillance protocols and from one year to another.
Laboratory code (required): local laboratory identifier/code assigned by national/regional CDI surveillance
coordinating centre. For the primary lab responsible for microbiological confirmation of CDI (not the code of the
national/reference laboratory). It is recommended to use the same laboratory codes as in EARS-Net.
Patient counter (required): provide an anonymised patient number that will permit linkage of patient data and
microbiological typing/susceptibility data, and between patient data from light and enhanced surveillance. Patient
identifiers must not be used.
Start date of surveillance period (required): start date for the CDI surveillance period in the entire hospital,
and should match the ‘Surveillance period: From’ on Form C.
Sample date (optional): the date on which the first positive diagnostic stool sample was taken from the patient
referred to on this form if available. Otherwise, the date the stool sample was taken resulting in the results
referred to on this form.
Age in years: patient age in years; if missing=UNK. Provide the patient’s age in months if the patient is less than
two years old.
Typing performed by a national/regional reference laboratory: typing of C. difficile isolates performed by a
laboratory that provides diagnostic, analytical and advisory services to other laboratories, nationally or sub-
nationally.
PCR ribotype of C. difficile isolate: C. difficile PCR ribotype as determined by conventional gel-electrophoresis
or capillary-based PCR ribotyping.
Ribotyping method: Method used to acquire PCR ribotype information, e.g.
capillary-based PCR ribotyping;
conventional gel-electrophoresis; other (please specify, e.g. whole genome sequencing.
Production of toxins A and/or B: production of toxins A and/or B as determined by PCR of tcdA and tcdB or by
EIA for TcdA and TcdB.
Production of binary toxin genes: production of binary toxin (CDT) as determined by PCR of cdtA and cdtB
Antimicrobial susceptibility testing performed by the national/regional reference laboratory: Testing
of C. difficile isolates for their susceptibility to antimicrobial agents performed by a laboratory that provides
diagnostic, analytical and advisory services to other laboratories, nationally or sub-nationally.
Antimicrobial susceptibility testing: MIC (minimum inhibitory concentration), test used for the determination
of the MIC and interpretation as S, I or R, i.e. susceptible, intermediate or resistant. Please report S, I or R using
(in order of preference) EUCAST clinical breakpoints
(http://www.eucast.org/clinical_breakpoints/), EUCAST
ECOFFs, CLSI or national breakpoints.
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European surveillance of Clostridium difficile infections
Form M: Isolate shipment data sheet (enhanced surveillance)
(one form for each isolate)
Network-Id: ____________________
Hospital code: ____________________
Laboratory code: ____________________
Patient counter: _________________________________________________________________
Internal patient code (optional)
: __________________________________________________
Start date of surveillance period: From
___ / ___ / 20___
(dd/mm/yyyy)
Age in years: ____; age if <2 years old: _____ months
Sample date (optional)
: ___ / ___ / 20___
(dd/mm/yyyy)
Microbiological results:
Typing performed by the national/regional reference laboratory:
Yes
No
PCR ribotype of C. difficile isolate: _____________
Method used to acquire ribotype:
Capillary-based PCR (i.e. CE PCR)
Gel-based PCR
Other, please specify: ______________________________________________________
Production of toxins A and/or B
Positive
Negative
Tests not performed
Presence of binary toxin genes
Positive
Negative
Tests not performed
Antimicrobial susceptibility testing performed by the national/regional reference laboratory:
Yes
No
Tests not performed
Metronidazole MIC: _____
mg/l by (method): _______
SIR: _____
Vancomycin MIC: _______
mg/l by (method): _______
SIR: _____
Moxifloxacin MIC: _______
mg/l by (method): _______
SIR: _____
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References
1.
Kuijper EJ, Coignard B, Tül P, et al. Emergence of Clostridium difficile-associated disease in North America and Europe.
Clin Microbiol Infect 2006; 12 (Suppl 6):2-18.
2.
Bauer MP, Notermans DW, van Benthem BH, et al. Clostridium difficile infection in Europe: a hospital-based survey.
Lancet 2011; 377:63-73.
3.
Barbut F, Mastrantonio P, Delmée M, et al. Prospective study of Clostridium difficile infections in Europe with
phenotypic and genotypic characterisation of the isolates. Clin Microbiol Infect 2007; 13:1048-1057.
4.
Suetens C. Clostridium difficile: summary of actions in the European Union. Euro Surveil . 2008 Jul 31;13(31).
5.
Tassios PT. Difficile indeed. Euro Surveil . 2016 Jul 21;21(29).
6.
Kola A, Wiuff C, Akerlund T, van Benthem BH, Coignard B, Lyytikainen O, et al. Survey of Clostridium difficile infection
surveil ance systems in Europe, 2011. Euro Surveil . 2016 Jul 21;21(29).
7.
Crobach MJ, Planche T, Eckert C, Barbut F, Terveer EM, Dekkers OM, et al. European Society of Clinical Microbiology
and Infectious Diseases: update of the diagnostic guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2016
Aug;22 Suppl 4:S63-81.
8.
van Dorp SM, Kinross P, Gastmeier P, Behnke M, Kola A, Delmee M, et al. Standardised surveil ance of Clostridium
difficile infection in European acute care hospitals: a pilot study, 2013. Euro Surveil . 2016 Jul 21;21(29).
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TECHNICAL DOCUMENT
Annex 1. Specialty code list
Specialty codes used for hospital specialisation, ward/unit specialty and consultant/patient specialty on Form C.
Categories (ward specialty)
Patient/consultant specialty code
Patient/consultant specialty name
Surgical specialties (SUR)
SURGEN
General surgery
Surgical specialties (SUR)
SURDIG
Digestive tract surgery
Surgical specialties (SUR)
SURORTR
Orthopaedics and surgical traumatology
Surgical specialties (SUR)
SURORTO
Orthopaedics
Surgical specialties (SUR)
SURTR
Traumatology
Surgical specialties (SUR)
SURCV
Cardio surgery and vascular surgery
Surgical specialties (SUR)
SURCARD
Cardio surgery
Surgical specialties (SUR)
SURVASC
Vascular surgery
Surgical specialties (SUR)
SURTHO
Thoracic surgery
Surgical specialties (SUR)
SURNEU
Neurosurgery
Surgical specialties (SUR)
SURPED
Paediatric general surgery
Surgical specialties (SUR)
SURTRANS
Transplantation surgery
Surgical specialties (SUR)
SURONCO
Surgery for cancer
Surgical specialties (SUR)
SURENT
ENT
Surgical specialties (SUR)
SUROPH
Ophthalmology
Surgical specialties (SUR)
SURMAXFAC
Maxil o-facial surgery
Surgical specialties (SUR)
SURSTODEN
Stomatology/Dentistry
Surgical specialties (SUR)
SURBURN
Burns care
Surgical specialties (SUR)
SURURO
Urology
Surgical specialties (SUR)
SURPLAS
Plastic and reconstructive surgery
Surgical specialties (SUR)
SUROTH
Other surgery
Medical specialties (MED)
MEDGEN
General medicine
Medical specialties (MED)
MEDGAST
Gastro-enterology
Medical specialties (MED)
MEDHEP
Hepatology
Medical specialties (MED)
MEDENDO
Endocrinology
Medical specialties (MED)
MEDONCO
Oncology
Medical specialties (MED)
MEDHEMA
Haematology
Medical specialties (MED)
MEDBMT
Bone marrow transplantation (BMT)
Medical specialties (MED)
MEDHEMBMT
Haematology/BMT
Medical specialties (MED)
MEDCARD
Cardiology
Medical specialties (MED)
MEDDERM
Dermatology
Medical specialties (MED)
MEDNEPH
Nephrology
Medical specialties (MED)
MEDNEU
Neurology
Medical specialties (MED)
MEDPNEU
Pneumology
Medical specialties (MED)
MEDRHEU
Rheumatology
Medical specialties (MED)
MEDID
Infectious diseases
Medical specialties (MED)
MEDTR
Medical traumatology
Medical specialties (MED)
MEDOTH
Other medical
Paediatrics (PED)
PEDGEN
Paediatrics general, not specialised
Neonatology (NEO)
PEDNEO
Neonatology (excl. healthy neonates)
Neonatology (NEO)
PEDBAB
Healthy neonates (paediatrics)
Neonatology (NEO)
ICUNEO
Neonatal ICU
Paediatrics (PED)
ICUPED
Paediatric ICU
Intensive Care Medicine (ICU)
ICUMED
Medical ICU
Intensive Care Medicine (ICU)
ICUSUR
Surgical ICU
Intensive Care Medicine (ICU)
ICUMIX
Mixed (polyvalent) ICU, general intensive or critical care
Intensive Care Medicine (ICU)
ICUSPEC
Specialised ICU
Intensive Care Medicine (ICU)
ICUOTH
Other ICU
Gynaecology/Obstetrics (GO)
GOOBS
Obstetrics /maternity
Gynaecology/Obstetrics (GO)
GOGYN
Gynaecology
Gynaecology/Obstetrics (GO)
GOBAB
Healthy neonates (maternity)
Geriatrics (GER)
GER
Geriatrics, care for the elderly
Psychiatrics (PSY)
PSY
Psychiatrics
Rehabilitation (RHB)
RHB
Rehabilitation
Long-term care (LTC)
LTC
Long-term care
OTHER (OTH)
OTH
Others not listed
Mixed (MIX)
MIX
Combination of specialties
18
TECHNICAL DOCUMENT
European surveillance of Clostridium difficile infections – surveillance protocol version 2.3
Annex 2. Other hospital variables that must
be added at national level before submission
to The European Surveillance System (TESSy)
RecordId. Unique identifier for each hospital within each network (combination of
[NetworkId]+[HospitalId]+[DateStartSurvey]).
RecordType. The record type tells TESSy which protocol and level the data relate to. For CDI surveillance, the
record type at hospital level (first level) is ‘HAICDI’ and ‘HAICDI$INF’ for case-level, infection and microbiological
information.
RecordTypeVersion. There may be more than one version of a record type.
Subject. Disease to report. For CDI, the subject is ‘HAICDI’.
DataSource. One country can have several data sources. This should correspond to the name of the data source
as defined in TESSy (e.g. CC-HAI, where ‘CC’ is a country code). One data source can be used to upload different
HAI data (e.g. SSI, ICU and PPS) if the coordinating centre is the same for different surveillance protocols.
ReportingCountry. Country reporting the record. The codes are provided in the TESSy metadata ‘coded values’.
DateUsedForStatistics. Start date of the survey in the hospital; this date allows to distinguish repeated surveys
for the same institution. Hospitals can upload more than one surveillance period in a single year.
Status. Status of reporting can be NEW/UPDATE or DELETE (deactivate). If set to NEW/UPDATE or left empty, a
new record is entered into the database. If set to DELETE, the record with the given RecordId will be deleted from
the TESSy database (or, rather, invalidated).
NetworkId. Unique identifier for each surveillance network within a Member State, selected and generated by the
Member State, e.g. for UK, EN, NI, SC or WA; for France, different CClin networks; this field is combined with the
hospital identifier to create a unique hospital code since different networks within one Member State may use the
same hospital code. Can be omitted if the hospital identifiers are unique within the reporting Member State.
Hospital location. Region (NUTS 1 code) where the hospital is located; NUTS 1 codes are provided in the TESSy
metadata ‘coded values’.
Hospital is part of national representative sample. ‘Yes’ if the hospital is part of a nationally representative
sample. Must be filled in (or at least checked) by the national/regional coordinator.
19
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