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

CompletadoFase 3ClinicalTrials.gov

ID: NCT03840148Tipo: INTERVENTIONALInicio: 7 de ago de 2019Fin estimado: 14 de dic de 2021

Neurología Enfermedades Infecciosas Urología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adult male and female
Documented diagnosis of pyuria
Documented diagnosis of cUTI or Acute Pyelonephritis (AP)

Criterios de exclusión

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

Intervenciones

drug

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.

drug

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.

Ubicaciones

Site 103203

Córdoba, Argentina

Patrocinadores

PrincipalVenatorx Pharmaceuticals, Inc.

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