RecruitingPhase 2NCT05826990

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

Single Group Phase 2 Study to Investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam Administered by IV Over 2 Hr in Male or Female Participants From Birth to Less Than 18 Years of Age Hospitalised With cUTI

Sponsor

Orchid Pharma Europe GmbH

Enrollment

40 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Complicated urinary tract infection

Summary

This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for cefepime-enmetazobactam to children with cUTI.

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called cefepime and enmetazobactam combination for people with complicated urinary tract infection. The study is currently recruiting participants at 8 locations. People eligible for this study include up to age 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcefepime and enmetazobactam combination

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

Locations(8)

Fakultní nemocnice Hradec Králové -Ústav klinické biochemie a diagnostiky

Hradec Králové, Czechia

Oblastni nemocnice Kolin, a.s., nemocnice Stredoceskeho kraje - Detske oddeleni

Kolín, Czechia

Hopital des Enfants

Toulouse, France

Debreceni Egyetem Klinikai Központ Gyermekgyógyászati Klinika

Debrecen, Hungary

Kanizsai Dorottya Hospital

Nagykanizsa, Hungary

SZPZOZ im. Dzieci Warszawy w Dziekanowie Leśnym

Łomianki, Poland

Národný ústav detských chorôb (NÚDCH)

Bratislava, Slovakia

Hospital Universitario La Paz

Madrid, Spain

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NCT05826990

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