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