Overview

Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

Status:
Recruiting
Trial end date:
2021-12-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Venatorx Pharmaceuticals, Inc.
Treatments:
Cefepime
Cephalosporins
Meropenem
Thienamycins
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