Trial · NCT03840148
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
NCT03840148, Phase 3, Completed, Venatorx Pharmaceuticals, Inc.; results first posted 2024-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections. Trials, record NCT03840148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03840148
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
- NCT number
- NCT03840148
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 661 participants, actual
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.
- Conditions
- Urinary Tract Infections, Acute Pyelonephritis
- Interventions
- Cefepime/VNRX-5133 (taniborbactam), Meropenem
- First posted
- 2019-02-15
- Last updated
- 2025-06-06
- Other registries' IDs
- eudract:2018-001451-13
- Results first posted
- 2024-05-29
Source ClinicalTrials.gov
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. |
| Secondary | Microbiologic Success at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. |
| Secondary | Clinical Success at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. |
| Secondary | Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. Symptomatic 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. |
| Secondary | Composite Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Secondary | Microbiological Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Secondary | Clinical Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Secondary | Composite Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Secondary | Microbiological Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Secondary | Clinical Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 registered outcomesOutcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Microbiologic Success at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Success at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | The extended 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 at least 1 study drug (cefepime/VNRX-5133 and/or meropenem) have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Composite Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Microbiological Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Composite Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Microbiological Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 outcomesResults by group331
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population | Cefepime/VNRX-5133 (Taniborbactam) | 207 | Participants | ||
| Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population | Meropenem | 83 | Participants | ||
| Microbiologic Success at Test of Cure (TOC) in the microITT Population | Cefepime/VNRX-5133 (Taniborbactam) | 229 | Participants | ||
| Microbiologic Success at Test of Cure (TOC) in the microITT Population | Meropenem | 95 | Participants | ||
| Clinical Success at Test of Cure (TOC) in the microITT Population | Cefepime/VNRX-5133 (Taniborbactam) | 251 | Participants | ||
| Clinical Success at Test of Cure (TOC) in the microITT Population | Meropenem | 116 | Participants | ||
| Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population | Cefepime/VNRX-5133 (Taniborbactam) | 216 | Participants | ||
| Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population | Meropenem | 86 | Participants | ||
| Composite Success at End of Treatment (EOT) in the microITT Population | Cefepime/VNRX-5133 (Taniborbactam) | 261 | Participants | ||
| Composite Success at End of Treatment (EOT) in the microITT Population | Meropenem | 123 | Participants |
1 to 10 of 331Source ClinicalTrials.gov
See all 331 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Drug Disposition | STARTED | Cefepime/VNRX-5133 (Taniborbactam) | 441 | |
| Study Drug Disposition | STARTED | Meropenem | 220 | |
| Study Drug Disposition | COMPLETED | Cefepime/VNRX-5133 (Taniborbactam) | 414 | |
| Study Drug Disposition | COMPLETED | Meropenem | 212 | |
| Study Drug Disposition | NOT COMPLETED | Cefepime/VNRX-5133 (Taniborbactam) | 27 | |
| Study Drug Disposition | NOT COMPLETED | Meropenem | 8 | |
| Study Completion Disposition | STARTED | Cefepime/VNRX-5133 (Taniborbactam) | 441 | |
| Study Completion Disposition | STARTED | Meropenem | 220 | |
| Study Completion Disposition | COMPLETED | Cefepime/VNRX-5133 (Taniborbactam) | 426 | |
| Study Completion Disposition | COMPLETED | Meropenem | 214 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Cefepime/VNRX-5133 (Taniborbactam) | 27 | 440 | 27 |
| other | Headache | Nervous system disorders | Meropenem | 8 | 217 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Cefepime/VNRX-5133 (Taniborbactam) | 18 | 440 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Meropenem | 5 | 217 | 5 |
| other | Constipation | Gastrointestinal disorders | Cefepime/VNRX-5133 (Taniborbactam) | 14 | 440 | 14 |
| other | Constipation | Gastrointestinal disorders | Meropenem | 3 | 217 | 3 |
| other | Hypertension | Vascular disorders | Cefepime/VNRX-5133 (Taniborbactam) | 9 | 440 | 10 |
| other | Hypertension | Vascular disorders | Meropenem | 2 | 217 | 2 |
| other | Nausea | Gastrointestinal disorders | Cefepime/VNRX-5133 (Taniborbactam) | 9 | 440 | 9 |
| other | Nausea | Gastrointestinal disorders | Meropenem | 2 | 217 | 2 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cefepime/VNRX-5133 (Taniborbactam) | 1 | 440 |
| Total, all-cause mortality | Meropenem | 0 | 217 |
| Total, other adverse events | Cefepime/VNRX-5133 (Taniborbactam) | 93 | 440 |
| Total, other adverse events | Meropenem | 37 | 217 |
| Total, serious adverse events | Cefepime/VNRX-5133 (Taniborbactam) | 9 | 440 |
| Total, serious adverse events | Meropenem | 4 | 217 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons24
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Microbiologic Success at Late Follow Up (LFU) in the ME Population | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Clinical Success at End of Treatment (EOT) in the microITT Population | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Composite Success at Late Follow Up (LFU) in the microITT Population | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Composite Success at End of Treatment (EOT) in the microITT Population | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Clinical Success at Test of Cure (TOC) in the microITT Population | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Clinical Success at Late Follow Up (LFU) in the CE Population | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Number of Patients With Treatment-Emergent Adverse Events | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Clinical Success at End of Treatment (EOT) in the Clinically Evaluable (CE) Population | Trial comparisons |
| Cefepime/VNRX-5133 (Taniborbactam) vs Meropenem: Clinical Success at Test of Cure (TOC) in the CE Population | Trial comparisons |
1 to 10 of 24
See all 24 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT03840148/registered?page=2