Trial Outcomes & Findings for COMBACTE-CDI Understanding the Burden of C. Difficile Infection (NCT NCT03503474)
NCT ID: NCT03503474
Last Updated: 2022-02-09
Results Overview
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.
COMPLETED
3240 participants
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).
2022-02-09
Participant Flow
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.
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.
Participant milestones
| Measure |
CDI Cases
No intervention: There is no intervention, this is observational only
|
CDI Negative Controls
No intervention: There is no intervention, this is observational only
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
3050
|
|
Overall Study
COMPLETED
|
103
|
3050
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CDI Cases
n=94 Participants
No intervention: There is no intervention, this is observational only
|
CDI Negative Controls
n=444 Participants
No intervention: There is no intervention, this is observational only
|
Total
n=538 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
72 years
n=94 Participants
|
55 years
n=444 Participants
|
58 years
n=538 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=94 Participants
|
203 Participants
n=444 Participants
|
254 Participants
n=538 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=94 Participants
|
241 Participants
n=444 Participants
|
284 Participants
n=538 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=94 Participants
|
137 participants
n=444 Participants
|
161 participants
n=538 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=94 Participants
|
13 participants
n=444 Participants
|
13 participants
n=538 Participants
|
|
Region of Enrollment
France
|
3 participants
n=94 Participants
|
24 participants
n=444 Participants
|
27 participants
n=538 Participants
|
|
Region of Enrollment
Greece
|
1 participants
n=94 Participants
|
4 participants
n=444 Participants
|
5 participants
n=538 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=94 Participants
|
3 participants
n=444 Participants
|
4 participants
n=538 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=94 Participants
|
43 participants
n=444 Participants
|
56 participants
n=538 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=94 Participants
|
9 participants
n=444 Participants
|
11 participants
n=538 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=94 Participants
|
38 participants
n=444 Participants
|
50 participants
n=538 Participants
|
|
Region of Enrollment
Romania
|
18 participants
n=94 Participants
|
57 participants
n=444 Participants
|
75 participants
n=538 Participants
|
|
Region of Enrollment
Slovakia
|
2 participants
n=94 Participants
|
8 participants
n=444 Participants
|
10 participants
n=538 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=94 Participants
|
93 participants
n=444 Participants
|
106 participants
n=538 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=94 Participants
|
15 participants
n=444 Participants
|
20 participants
n=538 Participants
|
|
Healthcare settings Hospital at time of sample collection
|
76 Participants
n=94 Participants
|
301 Participants
n=444 Participants
|
377 Participants
n=538 Participants
|
|
Healthcare settings Community at time of sample collection
|
18 Participants
n=94 Participants
|
143 Participants
n=444 Participants
|
161 Participants
n=538 Participants
|
|
Exposure to at least one antibiotic in the preceding 12 weeks to the sample
|
57 Participants
n=80 Participants • 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)
|
174 Participants
n=354 Participants • 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)
|
231 Participants
n=434 Participants • 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)
|
|
Contact with healthcare facilities in the preceding 6 months to the sample
|
60 Participants
n=80 Participants • 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)
|
183 Participants
n=372 Participants • 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)
|
243 Participants
n=452 Participants • 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)
|
|
Two or more co-morbidities
|
56 Participants
n=86 Participants • 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)
|
138 Participants
n=390 Participants • 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)
|
194 Participants
n=476 Participants • 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)
|
|
White cell count per microliter
|
14800 10^9 cells/μL
STANDARD_DEVIATION 13600 • n=70 Participants • 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)
|
10300 10^9 cells/μL
STANDARD_DEVIATION 8000 • n=291 Participants • 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)
|
11200 10^9 cells/μL
STANDARD_DEVIATION 9500 • n=361 Participants • 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)
|
|
Number of days of diarrhoea before the sample
|
3 days
n=68 Participants • 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)
|
3 days
n=258 Participants • 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)
|
3 days
n=326 Participants • 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)
|
|
Number of recurrent (previous) CDI
|
6 Participants
n=82 Participants • 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)
|
0 Participants
n=444 Participants • 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)
|
6 Participants
n=526 Participants • 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)
|
|
Hospital admission within 30 days of sample
|
13 Participants
n=87 Participants • 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)
|
43 Participants
n=408 Participants • 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)
|
56 Participants
n=495 Participants • 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)
|
|
30 days mortality rate
|
14 Participants
n=88 Participants • 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)
|
24 Participants
n=401 Participants • 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)
|
38 Participants
n=489 Participants • 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)
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
CDI Cases
n=103 Participants
No intervention: There is no intervention, this is observational only
|
CDI Negative Controls
n=3050 Participants
No intervention: There is no intervention, this is observational only
|
|---|---|---|
|
The Number of Cases of CDI
|
103 Participants
|
0 Participants
|
Adverse Events
CDI Cases
CDI Negative Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place