Comparison · NCT03840148-3ebfacc5
Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Composite Success at End of Treatment (EOT) in the microITT 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. Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Composite Success at End of Treatment (EOT) in the microITT Population. Trial comparisons, record NCT03840148-3ebfacc5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03840148-3ebfacc5
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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 | 0.891 | 0.85 | 0.922 | wilson | |
| Risk in group 2 | 0.86 | 0.794 | 0.908 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0306 | -0.032 | 0.104 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.959 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.729 | 2.41 | log | |
| Number needed to treat, for one more participant with the outcome on Cefepime/VNRX-5133 (Taniborbactam) than on Meropenem | 32.6 | 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 | Cefepime/VNRX-5133 (Taniborbactam) | Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.~Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes. | 261 | 293 | OG000 |
| Group 2 | Meropenem | Meropenem will be administered q8h IV over 30 minutes.~Meropenem: Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period. | 123 | 143 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Composite Success at End of Treatment (EOT) in the microITT Population
- Description
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.
- Time frame
- Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
- Population
The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
- NCT number
- NCT03840148
- Phases
- PHASE3
- Conditions
- Urinary Tract Infections, Acute Pyelonephritis
- Interventions
- Cefepime/VNRX-5133 (taniborbactam), Meropenem
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.
- Results first posted
- 2024-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03840148?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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