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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.

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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: 05 Apr 2024

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At a glance

  • Drugs Cefepime/enmetazobactam-Allecra-Therapeutics (Primary)
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Allecra Therapeutics

    • Most Recent Events

    • 09 Nov 2022 New trial record

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