Comparison · NCT03137173-sae
Ceftobiprole Medocaril vs Vancomycin+Aztreonam: 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. Ceftobiprole Medocaril vs Vancomycin+Aztreonam: serious adverse events. Trial comparisons, record NCT03137173-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03137173-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 | 0.018 | 0.00826 | 0.0386 | wilson | |
| Risk in group 2 | 0.0351 | 0.0202 | 0.0603 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0171 | -0.0442 | 0.00836 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.512 | 0.194 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 0.503 | 0.187 | 1.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ceftobiprole Medocaril than on Vancomycin+Aztreonam | 58.4 | 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 | Ceftobiprole Medocaril | Patients treated with ceftobiprole medocaril 500 mg every 8 hours (with dose adjustment for renal impairment).~Ceftobiprole medocaril: A reconstituted solution of 500 mg of ceftobiprole in 250 mL of water for injection was administered IV every 8 hours (with dose adjustment for renal impairment) for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor. Duration of each infusion: 2 hours. | 6 | 334 | EG000 |
| Group 2 | Vancomycin+Aztreonam | Patients treated with vancomycin 1000 mg (or 15 mg/kg) every 12 hours plus aztreonam 1000 mg every 12 hours (both with dose adjustment for renal impairment).~Vancomycin+aztreonam: vancomycin 1000 mg (or 15 mg/kg) every 12 hours (with dose adjustment for renal impairment). Vancomycin dose adjustment for obese and hypermetabolic patients was according to local standard of care. Duration of infusion: 2 hours.~Aztreonam for Injection for IV infusion must have been reconstituted with at least 3 mL sterile water for injection. The reconstituted solution of aztreonam must have been further diluted with 100 mL NaCl 0.9% solution for injection, resulting in an aztreonam concentration of 10 mg/mL (1%). Aztreonam 1000 mg was to be administered as a 0.5-hour IV infusion every 12 hours. If CLCR was \< 30 mL/min (i.e., severe renal impairment), the aztreonam dosage regimen might have been adjusted. The requirement for aztreonam therapy was to be reassessed at the 72-hour study visit. | 12 | 342 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 35 days after last treatment
Source ClinicalTrials.gov
Trial
- Title
- Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
- NCT number
- NCT03137173
- Phases
- PHASE3
- Conditions
- Acute Bacterial Skin and Skin Structure Infections
- Interventions
- ceftobiprole medocaril, vancomycin+aztreonam
- Lead sponsor
- Basilea Pharmaceutica
- Results first posted
- 2020-05-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03137173?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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