Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections (CERTAIN-1)

Venatorx Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Infections; Acute Pyelonephritis

Treatments: Drug: Cefepime/VNRX-5133 (taniborbactam); Drug: Meropenem

Study type: Interventional

Funder types: Industry

Identifiers

NCT03840148

VNRX-5133-201

2018-001451-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 661 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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661 participants in 2 patient groups

Cefepime/VNRX-5133 (taniborbactam)

Experimental group

Description:

Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.

Treatment:

Drug: Cefepime/VNRX-5133 (taniborbactam)

Meropenem

Active Comparator group

Description:

Meropenem will be administered q8h IV over 30 minutes.

Treatment:

Drug: Meropenem