Comparison · NCT03503474-57074fe8
CDI Cases vs CDI Negative Controls: The Number of Cases of CDI
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CDI Cases vs CDI Negative Controls: The Number of Cases of CDI. Trial comparisons, record NCT03503474-57074fe8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03503474-57074fe8
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.964 | 1 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00126 | wilson | |
| Risk difference, group 1 minus group 2 | 1 | 0.964 | 1 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on CDI Cases than on CDI Negative Controls | 1 | 1 | 1.04 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CDI Cases | No intervention: There is no intervention, this is observational only | 103 | 103 | OG000 |
| Group 2 | CDI Negative Controls | No intervention: There is no intervention, this is observational only | 0 | 3,050 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- The Number of Cases of CDI
- Description
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.
Source ClinicalTrials.gov
Trial
- Title
- COMBACTE-CDI Understanding the Burden of C. Difficile Infection
- NCT number
- NCT03503474
- Phases
- Conditions
- Clostridium Difficile Infection
- Interventions
- No intervention
- Lead sponsor
- University of Leeds
- Results first posted
- 2022-02-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03503474?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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