Trial Profile

A Single Group Treatment, Phase 2 study to investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in Male or Female Participants from birth to less than 18 years of age hospitalized with complicated urinary tract infections (cUTI) including Acute Pyelonephritis (AP). EMA Decision number of Paediatric Investigation Plan: P/0093/2019.

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 04 Sep 2026

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At a glance

20 Aug 2026 Planned End Date changed from 30 Mar 2026 to 21 May 2029.
20 Aug 2026 Planned primary completion date changed from 30 Sep 2025 to 21 May 2029.
09 Nov 2022 New trial record

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