A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 11, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

March 30, 2026

Conditions
Complicated Urinary Tract Infection
Interventions
DRUG

cefepime and enmetazobactam combination

Cefepime and enmetazobactam fixed dose combination administered intravenously every 8 hours as single drug formulation

Trial Locations (6)

500 05

RECRUITING

Fakultní nemocnice Hradec Králové -Ústav klinické biochemie a diagnostiky, Hradec Králové

Unknown

NOT_YET_RECRUITING

Hopital des Enfants, Toulouse

NOT_YET_RECRUITING

Debreceni Egyetem Klinikai Központ Gyermekgyógyászati Klinika, Debrecen

RECRUITING

SZPZOZ im. Dzieci Warszawy w Dziekanowie Leśnym, Łomianki

NOT_YET_RECRUITING

Národný ústav detských chorôb (NÚDCH), Bratislava

NOT_YET_RECRUITING

Hospital Universitario La Paz, Madrid

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Linical Co., Ltd.

INDUSTRY

lead

Allecra

INDUSTRY

NCT05826990 - A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI | Biotech Hunter | Biotech Hunter