Status:
COMPLETED
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
Lead Sponsor:
Venatorx Pharmaceuticals, Inc.
Conditions:
Urinary Tract Infections
Acute Pyelonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- Adult male and female
- Documented diagnosis of pyuria
- Documented diagnosis of cUTI or Acute Pyelonephritis (AP)
Exclusion
- 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
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
661 Patients enrolled
Trial Details
Trial ID
NCT03840148
Start Date
August 7 2019
End Date
December 14 2021
Last Update
June 6 2025
Active Locations (78)
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1
Site 184003
Buena Park, California, United States, 90620
2
Site 184002
Chula Vista, California, United States, 91911
3
Site 184001
La Mesa, California, United States, 91942
4
184012
Northridge, California, United States, 91324