Comparison · NCT02166476-52fdde6c
Meropenem-Vaborbactam vs Piperacillin-Tazobactam: Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit
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. Meropenem-Vaborbactam vs Piperacillin-Tazobactam: Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit. Trial comparisons, record NCT02166476-52fdde6c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02166476-52fdde6c
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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 | 0.984 | 0.955 | 0.995 | wilson | |
| Risk in group 2 | 0.94 | 0.895 | 0.966 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0448 | 0.0054 | 0.0905 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 1.01 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 4.05 | 1.11 | 14.8 | log | |
| Number needed to treat, for one more participant with the outcome on Meropenem-Vaborbactam than on Piperacillin-Tazobactam | 22.3 | 11 | 185 | from the risk difference interval |
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 | Meropenem-Vaborbactam | Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days. | 189 | 192 | OG000 |
| Group 2 | Piperacillin-Tazobactam | Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days. | 171 | 182 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit
- Description
This was the primary outcome measure for the Food and Drug Administration (FDA). For this composite outcome measure, overall success was achieved with a clinical outcome of Cure or Improvement and microbiologic outcome of Eradication at the end of intravenous treatment (EOIVT). Cure was defined as the complete resolution or significant improvement of the baseline signs and symptoms. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms. Eradication was defined using the FDA's colony-forming units (CFU)/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to \<10\^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).
- Time frame
- EOIVT (Days 5-14)
- Population
The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10\^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP
- NCT number
- NCT02166476
- Phases
- PHASE3
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis
- Interventions
- Meropenem-Vaborbactam, Piperacillin-Tazobactam, Levofloxacin, Saline
- Lead sponsor
- Melinta Therapeutics, Inc.
- Results first posted
- 2017-10-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02166476?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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