Trial Profile

A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 12 Jun 2025

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At a glance

Drugs Avibactam/aztreonam (Primary) ; Metronidazole
Indications Bacteraemia; Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Urinary tract infections
Focus Adverse reactions; Pharmacokinetics
Sponsors Pfizer

14 May 2025 Planned End Date changed from 17 Aug 2026 to 24 Jun 2026.
14 May 2025 Planned primary completion date changed from 17 Aug 2026 to 24 Jun 2026.
09 Aug 2024 Planned End Date changed from 18 Feb 2026 to 17 Aug 2026.

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