Phase 3
N=661
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
Urinary Tract Infections · Acute Pyelonephritis
Bottom Line
View on ClinicalTrials.gov: NCT03840148 ↗Enrolled (actual)
661
Serious AEs
2.0%
Results posted
May 2024
Primary outcome: Primary: Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population — 207; 83 Participants — p=0.0088
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cefepime/VNRX-5133 (taniborbactam) (Drug); Meropenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Venatorx Pharmaceuticals, Inc.
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population |
207; 83 | 0.0088 sig |
| SECONDARY Microbiologic Success at Test of Cure (TOC) in the microITT Population |
229; 95 | — |
| SECONDARY Clinical Success at Test of Cure (TOC) in the microITT Population |
251; 116 | — |
| SECONDARY Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population |
216; 86 | — |
| SECONDARY Composite Success at End of Treatment (EOT) in the microITT Population |
261; 123 | — |
| SECONDARY Microbiological Success at End of Treatment (EOT) in the microITT Population |
284; 139 | — |
| SECONDARY Clinical Success at End of Treatment (EOT) in the microITT Population |
265; 127 | — |
| SECONDARY Composite Success at Late Follow Up (LFU) in the microITT Population |
187; 74 | — |
| SECONDARY Microbiological Success at Late Follow Up (LFU) in the microITT Population |
207; 90 | — |
| SECONDARY Clinical Success at Late Follow Up (LFU) in the microITT Population |
238; 102 | — |
| SECONDARY Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population |
271; 128 | — |
| SECONDARY Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population |
57; 26; 1 | — |
| SECONDARY Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population |
65; 28; 1 | — |
| SECONDARY Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population |
57; 28; 1 | — |
| SECONDARY Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population |
47; 16; 0 | — |
| SECONDARY Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population |
50; 18; 0 | — |
| SECONDARY Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population |
54; 25; 0 | — |
| SECONDARY Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population |
45; 13; 0 | — |
| SECONDARY Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population |
48; 16; 0 | — |
| SECONDARY Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population |
49; 20; 0 | — |
| SECONDARY Composite Success at End of Treatment (EOT) in the Microbiologically-Evaluable (ME) Population |
259; 121 | — |
| SECONDARY Microbiologic Success at End of Treatment (EOT) in the ME Population |
279; 137 | — |
| SECONDARY Composite Success at Test of Cure (TOC) in the ME Population |
195; 76 | — |
| SECONDARY Microbiologic Success at Test of Cure (TOC) in the ME Population |
214; 88 | — |
| SECONDARY Composite Success at Late Follow Up (LFU) in the ME Population |
178; 69 | — |
| SECONDARY Microbiologic Success at Late Follow Up (LFU) in the ME Population |
192; 84 | — |
| SECONDARY Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population |
56; 26; 1 | — |
| SECONDARY Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population |
62; 28; 1 | — |
| SECONDARY Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population |
44; 12; 0 | — |
| SECONDARY Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population |
46; 14; 0 | — |
| SECONDARY Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population |
44; 11; 0 | — |
| SECONDARY Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population |
45; 14; 0 | — |
| SECONDARY Clinical Success at End of Treatment (EOT) in the Clinically Evaluable (CE) Population |
384; 187 | — |
| SECONDARY Clinical Success at Test of Cure (TOC) in the CE Population |
343; 162 | — |
| SECONDARY Clinical Success at Late Follow Up (LFU) in the CE Population |
321; 142 | — |
| SECONDARY Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population |
63; 31; 6; 2 | — |
| SECONDARY Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population |
56; 23; 4; 2 | — |
| SECONDARY Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population |
52; 19; 3; 1 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population |
2; 2; 1; 1; 14; 3 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population |
2; 2; 0; 1; 12; 1 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population |
1; 2; 0; 1; 12; 1 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population |
100; 100; 100; 88.9; 100; 95.0 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population |
100; 50.0; 81.1; 61.1; 100; 60.0 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population |
100; 50.0; 73.0; 50.0; 100; 65.0 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population |
2; 2; 1; 1; 14; 3 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population |
2; 2; 0; 1; 11; 0 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population |
1; 2; 1; 12; 1; 130 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population |
100; 100; 100; 100; 100; 95.0 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population |
100; 0; 87.5; 66.7; 100; 64.7 | — |
| SECONDARY Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population |
100; 50.0; 78.1; 53.3; 68.4; 71.4 | — |
Summary
This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.
Eligibility Criteria
Inclusion Criteria
- Adult male and female
- Documented diagnosis of pyuria
- Documented diagnosis of cUTI or Acute Pyelonephritis (AP)
Exclusion Criteria
- Receipt of effective antibacterial drug therapy for cUTI for more than 24 hours during the previous 72 hours prior to randomization
- A urine culture result is resistant to meropenem or a gram negative pathogen is not identified or more than 2 microorganisms are isolated or a confirmed fungal UTI is identified
- Required use of nonstudy systemic bacterial therapy
- Suspected or confirmed prostatitis or urinary tract symptoms attributable to sexually transmitted disease
- Patients with perinephric or renal abscess
- Patients with renal transplantation or receiving hemodialysis or peritoneal dialysis
- Abnormal labs
Data sourced from ClinicalTrials.gov (NCT03840148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.