Trial · NCT03503474
COMBACTE-CDI Understanding the Burden of C. Difficile Infection
NCT03503474, Completed, University of Leeds; results first posted 2022-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. COMBACTE-CDI Understanding the Burden of C. Difficile Infection. Trials, record NCT03503474. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03503474
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COMBACTE-CDI Understanding the Burden of C. Difficile Infection
- NCT number
- NCT03503474
- Status
- Completed
- Enrollment
- 3,240 participants, actual
- Lead sponsor
- University of Leeds
- Conditions
- Clostridium Difficile Infection
- Interventions
- No intervention
- First posted
- 2018-04-19
- Last updated
- 2022-02-09
- Results first posted
- 2022-02-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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). | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Cases of CDI | CDI Cases | 103 | Participants | ||
| The Number of Cases of CDI | CDI Negative Controls | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CDI Cases | 103 | |
| Overall Study | STARTED | CDI Negative Controls | 3,050 | |
| Overall Study | COMPLETED | CDI Cases | 103 | |
| Overall Study | COMPLETED | CDI Negative Controls | 3,050 | |
| Overall Study | NOT COMPLETED | CDI Cases | 0 | |
| Overall Study | NOT COMPLETED | CDI Negative Controls | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CDI Cases | 14 | 88 |
| Total, all-cause mortality | CDI Negative Controls | 24 | 401 |
| Total, other adverse events | CDI Cases | 0 | 0 |
| Total, other adverse events | CDI Negative Controls | 0 | 0 |
| Total, serious adverse events | CDI Cases | 0 | 0 |
| Total, serious adverse events | CDI Negative Controls | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39535868 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CDI Cases vs CDI Negative Controls: The Number of Cases of CDI | Trial comparisons |
| CDI Cases vs CDI Negative Controls: deaths from any cause | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03503474
GET https://conductscience.org/api/trials/v1/NCT03503474/registered