Comparison · NCT03580044-sae
Aztreonam- Avibactam (ATM- AVI) vs Best Available Therapy (BAT): serious adverse events
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. Aztreonam- Avibactam (ATM- AVI) vs Best Available Therapy (BAT): serious adverse events. Trial comparisons, record NCT03580044-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03580044-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 | 0.417 | 0.193 | 0.68 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.583 | -0.807 | 0.125 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.417 | 0.213 | 0.814 | 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 a serious adverse event on Aztreonam- Avibactam (ATM- AVI) than on Best Available Therapy (BAT) | 1.71 | 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 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance \>50 milliliters per minute (mL/min) and \>30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance \>15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. | 5 | 12 | EG000 |
| Group 2 | Best Available Therapy (BAT) | Participants who were hospitalized with a diagnosis of cIAI, NP, HAP, VAP, cUTI or BSI received Best Available Therapy (BAT) based upon site practice and local epidemiology for a maximum of 14 days. Participants with cIAI in the BAT arm received metronidazole if BAT did not provide adequate anaerobic coverage. | 2 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-cause mortality: From randomization up to late follow-up visit (up to 45 days); SAEs and non-SAEs: From first dose of study drug up to the late follow-up visit (up to maximum of 45 days)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
- NCT number
- NCT03580044
- Phases
- PHASE3
- Conditions
- Serious Bacterial Infection
- Interventions
- ATM-AVI, BAT
- Lead sponsor
- Pfizer
- Results first posted
- 2024-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03580044?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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