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| Name | Class |
|---|---|
| Innovative Medicines Initiative | OTHER |
| UMC Utrecht | OTHER |
| Leiden University Medical Center | OTHER |
| National laboratory for Health, Environment and Food, Slovenia |
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Clostridium difficile infection (CDI) is the most common cause of antibiotic associated diarrhoea in the western world. The infection causes significant diarrhoea, which in some cases can be serious and lead to secondary complications and even death. The infection is particularly an issue in elderly, frail patient, who are often already burdened with several other medical issues. Recent work has demonstrated that numerous cases are missed, either due to inadequate diagnostic tests or lack of clinical suspicion.
The public-private partnership in COMBACTE-CDI will quantify the burden of CDI via a large, complex, multi-centre, multi-country study, and describe current management practices. An increased understanding of the CDI burden across Europe and better understanding of transmission of the organism will provide a basis for the further development of public health interventions and practices.
Based on a previous successful study model (EUCLID), hospitals/laboratories of interest which carry out diagnostic testing of samples from both in-patients and community patients (including Long-Term Care Facilities patients) will be approached for inclusion in the study. Samples sent to the sites on the selected study date (regardless of test requested) will be tested at a central laboratory for CDI to look for missed cases of CDI. A follow up case/control study will collect data on outcomes and risk factors. Data will be used to construct transmission models and cost effective-ness models. Ultimately, a best practice model for CDI management will be developed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDI cases |
| ||
| CDI negative controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | There is no intervention, this is observational only |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Cases of CDI | This outcome measure is to indicate the number of participants with a sample that returned a positive test result (=CDI cases) at the coordinating laboratory from the overall total number of participants. The number of CDI cases and negative controls are the number of participants with a sample that returned a positive or negative test result, respectively. Therefore the "CDI negative controls" arm did not return a positive test result. The proportion of participants that returned a positive test result compared to the total of participants (=number of participants in the "CDI cases" arm divided by the number of total participants in both arms) can be inferred from this outcome measure. | Samples were received between July and December 2018 (at time of diarrheal episode) and test performed during that timeframe to identify the number of CDI cases (positive test result) and the number of CDI negative controls (negative test result). |
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Inclusion Criteria:
Exclusion Criteria:
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Anyone who has a diarrhoeal faecal sample submitted to the laboratories in the study for testing on the day of interest, regardless of test requested
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| Name | Affiliation | Role |
|---|---|---|
| Mark Wilcox, MD | University of Leeds | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leeds | Leeds | West Yorkshire | LS1 3EX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39535868 | Derived | Rupnik M, Viprey V, Janezic S, Tkalec V, Davis G, Sente B, Devos N, Muller BH, Santiago-Allexant E, Cleuziat P, Wilcox M, Davies K; COMBACTE-CDI consortium. Distribution of Clostridioides difficile ribotypes and sequence types across humans, animals and food in 13 European countries. Emerg Microbes Infect. 2024 Dec;13(1):2427804. doi: 10.1080/22221751.2024.2427804. Epub 2024 Nov 27. |
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Residual samples received during the study period were tested for Clostridioides difficile infection (CDI) at the coordinating laboratory. Informed consent is not required for the use of anonymised residual material. The number of CDI cases and negative controls are the number of participants with a sample that returned a positive or negative test result, respectively. Duplicate samples were excluded and therefore not completed. Test result was not reported back to the laboratories.
Anyone who has a diarrhoeal faecal sample submitted to the laboratories in the study for testing on the day of interest, regardless of test requested. The result of this observational study did not impact on patient treatment and management at the submitting laboratories.
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| ID | Title | Description |
|---|---|---|
| FG000 | CDI Cases | No intervention: There is no intervention, this is observational only |
| FG001 | CDI Negative Controls | No intervention: There is no intervention, this is observational only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A clinical report form was requested 6 months after collection of residual diarrhoeal samples for all positive CDI cases and a proportion of CDI negative controls (case-control study analysis population). The number of baseline participants is different from the participant Flow module, and is the number of CDI cases with completed clinical report form and an appropriate number of CDI negative controls from the pool of samples received to obtain a ratio of approximately 1:4 (Cases:Controls)
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| ID | Title | Description |
|---|---|---|
| BG000 | CDI Cases | No intervention: There is no intervention, this is observational only |
| BG001 | CDI Negative Controls | No intervention: There is no intervention, this is observational only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Cases of CDI | This outcome measure is to indicate the number of participants with a sample that returned a positive test result (=CDI cases) at the coordinating laboratory from the overall total number of participants. The number of CDI cases and negative controls are the number of participants with a sample that returned a positive or negative test result, respectively. Therefore the "CDI negative controls" arm did not return a positive test result. The proportion of participants that returned a positive test result compared to the total of participants (=number of participants in the "CDI cases" arm divided by the number of total participants in both arms) can be inferred from this outcome measure. | The number of CDI cases and negative controls are the number of participants with a sample that returned a positive or negative test result, respectively. Therefore the "CDI negative controls" arms did not return a positive test result. | Posted | Count of Participants | Participants | No | Samples were received between July and December 2018 (at time of diarrheal episode) and test performed during that timeframe to identify the number of CDI cases (positive test result) and the number of CDI negative controls (negative test result). |
Mortality rate (within 30 days of sample collection) was reported 6 months after sample collection, and therefore did not impact on participant management and treatment. This is provided as a study-specific measure to report on the difference in 30 days mortality rate between CDI cases and CDI negative controls. The total number of participants at risk are the number of participants with data obtained on this study-specific measure, 6 months after sample collection.
For this observational study, serious and other adverse events were not monitored/assessed as participants were not enrolled in a clinical trial. Therefore the number of participants at risk for serious and other adverse events is shown as "0". However, all cause mortality (within 30 days of sample) was reported as an observation only, to report on the difference in 30 days mortality rate between CDI cases and CDI negative controls
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDI Cases | No intervention: There is no intervention, this is observational only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Mark Wilcox | University of Leeds | +441133926818 | mark.wilcox@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2018 | Jul 28, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2019 | Jul 28, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| OTHER |
| Universitätsklinikum Köln | OTHER |
| Universiteit Antwerpen | OTHER |
| National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy | OTHER |
| Universität Tübingen | OTHER |
| Pfizer | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
| BioMérieux | INDUSTRY |
| AstraZeneca | INDUSTRY |
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
| Da Volterra | INDUSTRY |
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residual diagnostic faecal samples
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Healthcare settings Hospital at time of sample collection | Count of Participants | Participants |
|
| Healthcare settings Community at time of sample collection | Count of Participants | Participants |
|
| Exposure to at least one antibiotic in the preceding 12 weeks to the sample | Number of participants with data on this study-specific baseline measure as reported in the clinical report form (data obtained 6 months after sample collection) | Count of Participants | Participants |
|
| Contact with healthcare facilities in the preceding 6 months to the sample | Number of participants with data on this study-specific baseline measure as reported in the clinical report form (data obtained 6 months after sample collection) | Count of Participants | Participants |
|
| Two or more co-morbidities | Number of participants with data on this study-specific baseline measure as reported in the clinical report form (data obtained 6 months after sample collection) | Count of Participants | Participants |
|
| White cell count per microliter | Number of participants with data on this study-specific baseline measure as reported in the clinical report form (data obtained 6 months after sample collection) | Mean | Standard Deviation | 10^9 cells/μL |
|
| Number of days of diarrhoea before the sample | Number of participants with data on this study-specific baseline measure as reported in the clinical report form (data obtained 6 months after sample collection) | Median | Inter-Quartile Range | days |
|
| Number of recurrent (previous) CDI | Number of participants with data on this study-specific baseline measure as reported in the clinical report form (data obtained 6 months after sample collection) | Count of Participants | Participants |
|
| Hospital admission within 30 days of sample | A clinical report form was requested 6 months after collection of residual diarrhoeal samples for all positive CDI cases and a proportion of CDI negative controls (case-control study analysis population). Therefore all baseline characteristics presented were obtained retrospectively, including the information on whether the participant was admitted to hospital within 30 days after collection of that same sample, and is considered a study-specific measure. | Number of participants with data on this study-specific baseline measure as reported in the clinical report form (data obtained 6 months after sample collection) | Count of Participants | Participants |
|
| 30 days mortality rate | A clinical report form was requested 6 months after collection of residual diarrhoeal samples for all positive CDI cases and a proportion of CDI negative controls (case-control study analysis population). Therefore all baseline characteristics presented were obtained retrospectively, including the information on whether the participant died within 30 days after collection of that same sample, and is considered a study-specific measure. | Number of participants with data on this study-specific baseline measure as reported in the clinical report form (data obtained 6 months after sample collection) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | CDI Cases | No intervention: There is no intervention, this is observational only |
| OG001 | CDI Negative Controls | No intervention: There is no intervention, this is observational only |
|
|
| 14 |
| 88 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | CDI Negative Controls | No intervention: There is no intervention, this is observational only | 24 | 401 | 0 | 0 | 0 | 0 |
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