Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
Completed · Phase 3 · Has a placebo group
Conditions studied: Urinary Tract Infections, Acute Pyelonephritis
In brief
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.
Key facts
- Study ID
- NCT03840148
- Run by
- Venatorx Pharmaceuticals, Inc.
- People needed
- 661
- Starts
- 2019-08-07
- Expected to finish
- 2021-12-14
- Last updated by the study team
- 2025-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult male and female
- Documented diagnosis of pyuria
- Documented diagnosis of cUTI or Acute Pyelonephritis (AP)
You may not qualify if…
- 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
Where it is running
- Site 184002 — Chula Vista, California, United States
- Site 184001 — La Mesa, California, United States
- 184012 — Northridge, California, United States
- Site 103203 — Córdoba, Argentina
- Site 107601 — Belo Horizonte, Brazil
- Site 107608 — São Paulo, Brazil
- Site 110009 — Gabrovo, Bulgaria
- Site 110002 — Pleven, Bulgaria
- Site 110007 — Plovdiv, Bulgaria
- Site 110003 — Rousse, Bulgaria
- Site 110010 — Sofia, Bulgaria
- Site 110004 — Sofia, Bulgaria
- Site 110005 — Sofia, Bulgaria
- Site 110008 — Sofia, Bulgaria
- Site 110001 — Veliko Tarnovo, Bulgaria
- Site 156022 — Baotou, China
- Site 156002 — Beijing, China
- Site 156006 — Beijing, China
- Site 156015 — Chendu, China
- Site 156011 — Chongqing, China
- Site 156012 — Chongqing, China
- Site 156004 — Dalian, China
- Site 156030 — Fujian, China
- Site 156014 — Guangdong, China
- Site 184003 — Buena Park, California, United States
Full record on ClinicalTrials.gov
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