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