Comparison · NCT01110421-4ba0b39e
Doripenem vs Cefepime: The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Doripenem vs Cefepime: The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit. Trial comparisons, record NCT01110421-4ba0b39e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01110421-4ba0b39e
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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 | 0.6 | 0.231 | 0.882 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.4 | -0.769 | 0.316 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.6 | 0.293 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Doripenem than on Cefepime | 2.5 | from the risk difference interval | the interval includes no difference |
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 | Doripenem | Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. | 3 | 5 | OG000 |
| Group 2 | Cefepime | Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. | 2 | 2 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
- Description
The participants were classified as cure if they had resolution or clinical improvement of signs and symptoms of pneumonia, favorable response at End of treatment for IV study (EIV) visit; had no fever; improvement or no progression of radiographic findings of pneumonia on chest X ray; improvement in oxygenation or discontinued mechanical ventilation in intubated participants; and not received nonstudy systemic antibacterial therapy for pneumonia.
- Time frame
- TOC (7 to 14 days after the last dose of study medication therapy)
- Population
Clinical Intent-To-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
- NCT number
- NCT01110421
- Phases
- PHASE3
- Conditions
- Pneumonia, Bacterial, Community-Acquired Infections, Nosocomial Infection, Pneumonia, Ventilator-Associated
- Interventions
- Cefepime placebo, Cefepime, Doripenem, Doripenem placebo, Amoxicillin/clavulanate potassium
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2014-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01110421?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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