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

  • STATUS
    Recruiting
  • days left to enroll
    6
  • participants needed
    582
  • sponsor
    Venatorx Pharmaceuticals, Inc.
Updated on 28 June 2021
meropenem
cefepime
pyelonephritis
acute pyelonephritis

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.

Details
Condition Urinary tract infection, Recurrent Urinary Tract Infection, Recurrent Urinary Tract Infections, Acute Pyelonephritis, Urinary Tract Infections, pyelonephritis, acute, urinary tract infection (uti), urinary infection, recurrent utis
Treatment Meropenem, Cefepime/VNRX-5133, Cefepime/VNRX-5133 (taniborbactam)
Clinical Study IdentifierNCT03840148
SponsorVenatorx Pharmaceuticals, Inc.
Last Modified on28 June 2021

Eligibility

Yes No Not Sure

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
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