Comparison · NCT02166476-0ffab2b7
Meropenem-Vaborbactam vs Piperacillin-Tazobactam: Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure 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 m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit. Trial comparisons, record NCT02166476-0ffab2b7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02166476-0ffab2b7
On this page
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 | 0.667 | 0.597 | 0.73 | wilson | |
| Risk in group 2 | 0.577 | 0.504 | 0.646 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0897 | -0.00842 | 0.186 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.985 | 1.36 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.964 | 2.23 | log | |
| Number needed to treat, for one more participant with the outcome on Meropenem-Vaborbactam than on Piperacillin-Tazobactam | 11.1 | 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 | 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. | 128 | 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. | 105 | 182 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit
- Description
This was the primary outcome measure for the European Medicines Agency (EMA). For this measure, a microbiologic outcome of Eradication was defined using the EMA's CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to \<10\^3 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
- Test of cure (TOC) (Days 15-23)
- 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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02166476-0ffab2b7