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

V

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

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

Trial documents
2

Trial contacts and locations

78

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Data sourced from clinicaltrials.gov

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