Comparison · NCT01370616-sae
Ertapenem Sodium vs Piperacillin/Tazobactam Sodium: serious adverse events
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. Ertapenem Sodium vs Piperacillin/Tazobactam Sodium: serious adverse events. Trial comparisons, record NCT01370616-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01370616-sae
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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 | 0.0618 | 0.039 | 0.0968 | wilson | |
| Risk in group 2 | 0.0436 | 0.0251 | 0.0747 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0182 | -0.0204 | 0.0577 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 0.69 | 2.91 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 0.676 | 3.08 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ertapenem Sodium than on Piperacillin/Tazobactam Sodium | 55 | 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 | Ertapenem Sodium | Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28 | 17 | 275 | EG000 |
| Group 2 | Piperacillin/Tazobactam Sodium | Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28 | 12 | 275 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through 14-Day follow-up (up to Day 42)
Source ClinicalTrials.gov
Trial
- Title
- Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
- NCT number
- NCT01370616
- Phases
- PHASE3
- Conditions
- Infection; Diabetic Foot
- Interventions
- Ertapenem sodium, Piperacillin/tazobactam sodium, Piperacillin/tazobactam-matching placebo, Amoxicillin/clavulunate potassium
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2014-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01370616?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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