Comparison · NCT03358576-a93fe531
Sulopenem vs Ertapenem: Percentage of Participants With Clinical Success
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. Sulopenem vs Ertapenem: Percentage of Participants With Clinical Success. Trial comparisons, record NCT03358576-a93fe531. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03358576-a93fe531
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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 | 0.835 | 0.784 | 0.876 | wilson | |
| Risk in group 2 | 0.853 | 0.806 | 0.891 | wilson | |
| Risk difference, group 1 minus group 2 | -0.018 | -0.0814 | 0.0447 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.979 | 0.909 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.872 | 0.541 | 1.4 | log | |
| Number needed to treat, for one fewer participant with the outcome on Sulopenem than on Ertapenem | 55.4 | 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 | Sulopenem | Sulopenem 1000 mg IV once daily for at least 5 days, followed by Sulopenem-Etzadroxil/Probenecid 500 mg PO twice daily to complete 7-10 days of treatment~Sulopenem-Etzadroxil/Probenecid: Antibiotic for complicated intra-abdominal infection~Sulopenem: Antibiotic for complicated intra-abdominal infection | 208 | 249 | OG000 |
| Group 2 | Ertapenem | Ertapenem 1000 mg IV once daily for at least 5 days, followed by ciprofloxacin 500 mg PO twice daily along with metronidazole 500 mg PO four times daily. If patient is found to have causative pathogens that are resistant to ciprofloxacin they will receive amoxicillin-clavulanate 875 mg PO twice daily instead~Ertapenem: Antibiotic for complicated intra-abdominal infection~Ciprofloxacin: Antibiotic for complicated intra-abdominal infection~Metronidazole: Antibiotic for complicated intra-abdominal infection~Amoxicillin-Clavulanate: Antibiotic for complicated intra-abdominal infection | 227 | 266 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants With Clinical Success
- Description
- Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions
- Time frame
- Day 11-14 +/- 1 day
- Population
- micro-MITT population
Source ClinicalTrials.gov
Trial
- Title
- Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
- NCT number
- NCT03358576
- Phases
- PHASE3
- Conditions
- Intra Abdominal Infections
- Interventions
- Ertapenem, Sulopenem-Etzadroxil/Probenecid, Ciprofloxacin, Metronidazole, Amoxicillin-Clavulanate, Sulopenem
- Lead sponsor
- Iterum Therapeutics, International Limited
- Results first posted
- 2020-12-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03358576?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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