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Clinical trial

A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis

ID
Name
VNRX-5133-201
Description
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.
Trial arms
Trial start
2019-08-07
Estimated PCD
2021-12-14
Trial end
2021-12-14
Status
Completed
Phase
Early phase I
Treatment
Cefepime/VNRX-5133 (taniborbactam)
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
Arms:
Cefepime/VNRX-5133 (taniborbactam)
Meropenem
Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.
Arms:
Meropenem
Size
661
Primary endpoint
Composite of microbiological eradication and symptomatic clinical success in the microbiological intent-to-treat (microITT) population at test of cure (TOC)
Days 19-23
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 661, 'type': 'ACTUAL'}}
Updated at
2024-02-15

1 organization

2 products

2 indications

Organization
Venatorx Pharmaceuticals
Product
Cefepime + VNRX-5133
Indication
Urinary Tract Infections
Indication
Pyelonephritis
Product
Meropenem