Comparison · NCT03894046-2465327a
Part A - Group 1 vs Part A - Group 2: Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population
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. Part A - Group 1 vs Part A - Group 2: Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population. Trial comparisons, record NCT03894046-2465327a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03894046-2465327a
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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 | 0.19 | 0.112 | 0.304 | wilson | |
| Risk in group 2 | 0.323 | 0.22 | 0.446 | wilson | |
| Risk difference, group 1 minus group 2 | -0.132 | -0.278 | 0.0213 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.59 | 0.316 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.494 | 0.217 | 1.13 | log | |
| Number needed to treat, for one fewer participant with the outcome on Part A - Group 1 than on Part A - Group 2 | 7.57 | 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 | Part A - Group 1 | Experimental.~Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h; | 12 | 63 | OG000 |
| Group 2 | Part A - Group 2 | Control group (active comparator).~Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. | 20 | 62 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population
- Description
- The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.
- Time frame
- 28 Days
- Population
CRABC m-MITT (Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex Microbiologically Modified Intent-to-Treat Population).~The CRABC m-MITT Population included patients who met m-MITT criteria and had a baseline ABC organism that was confirmed to be carbapenem-resistant (MIC of imipenem/meropenem ≥8 ug/mL) by the central laboratory or by the local laboratory.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
- NCT number
- NCT03894046
- Phases
- PHASE3
- Conditions
- Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia, Colistin Resistant ABC
- Interventions
- Sulbactam, Durlobactam, Colistin, Imipenem/Cilastatin 500 mg/500 mg
- Lead sponsor
- Entasis Therapeutics
- Results first posted
- 2023-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03894046?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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