Clostridium Difficile Infection
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
There is no intervention, this is observational only
Sponsors
Innovative Medicines Initiative
UMC Utrecht
Leiden University Medical Center
National laboratory for Health, Environment and Food, Slovenia
Universitätsklinikum Köln
Universiteit Antwerpen
National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy
Universität Tübingen
Pfizer
GlaxoSmithKline
BioMérieux
AstraZeneca
Sanofi Pasteur, a Sanofi Company
Da Volterra
University of Leeds
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Any repeat samples
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Cases of CDI | 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). | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| CDI Cases No intervention: There is no intervention, this is observational only | 94 |
| CDI Negative Controls No intervention: There is no intervention, this is observational only | 444 |
| Total | 538 |
Baseline characteristics
| Characteristic | Total | CDI Negative Controls | CDI Cases |
|---|---|---|---|
| 30 days mortality rate | 38 Participants | 24 Participants | 14 Participants |
| Age, Customized | 58 years | 55 years | 72 years |
| Contact with healthcare facilities in the preceding 6 months to the sample | 243 Participants | 183 Participants | 60 Participants |
| Exposure to at least one antibiotic in the preceding 12 weeks to the sample | 231 Participants | 174 Participants | 57 Participants |
| Healthcare settings Community at time of sample collection | 161 Participants | 143 Participants | 18 Participants |
| Healthcare settings Hospital at time of sample collection | 377 Participants | 301 Participants | 76 Participants |
| Hospital admission within 30 days of sample | 56 Participants | 43 Participants | 13 Participants |
| Number of days of diarrhoea before the sample | 3 days | 3 days | 3 days |
| Number of recurrent (previous) CDI | 6 Participants | 0 Participants | 6 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Belgium | 13 participants | 13 participants | 0 participants |
| Region of Enrollment France | 27 participants | 24 participants | 3 participants |
| Region of Enrollment Greece | 5 participants | 4 participants | 1 participants |
| Region of Enrollment Ireland | 4 participants | 3 participants | 1 participants |
| Region of Enrollment Italy | 56 participants | 43 participants | 13 participants |
| Region of Enrollment Netherlands | 11 participants | 9 participants | 2 participants |
| Region of Enrollment Poland | 50 participants | 38 participants | 12 participants |
| Region of Enrollment Romania | 75 participants | 57 participants | 18 participants |
| Region of Enrollment Slovakia | 10 participants | 8 participants | 2 participants |
| Region of Enrollment Spain | 106 participants | 93 participants | 13 participants |
| Region of Enrollment Sweden | 20 participants | 15 participants | 5 participants |
| Region of Enrollment United Kingdom | 161 participants | 137 participants | 24 participants |
| Sex: Female, Male Female | 254 Participants | 203 Participants | 51 Participants |
| Sex: Female, Male Male | 284 Participants | 241 Participants | 43 Participants |
| Two or more co-morbidities | 194 Participants | 138 Participants | 56 Participants |
| White cell count per microliter | 11200 10^9 cells/μL STANDARD_DEVIATION 9500 | 10300 10^9 cells/μL STANDARD_DEVIATION 8000 | 14800 10^9 cells/μL STANDARD_DEVIATION 13600 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 88 | 24 / 401 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 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).
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDI Cases | The Number of Cases of CDI | 103 Participants |
| CDI Negative Controls | The Number of Cases of CDI | 0 Participants |