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An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics and Safety of Augmentin Extra Strength (ES)-600 Suspension in Children Presenting With Community Acquired Pneumonia (CAP) and Acute Bacterial Rhinosinusitis (ABRS) in Brazil

Trial Profile

An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics and Safety of Augmentin Extra Strength (ES)-600 Suspension in Children Presenting With Community Acquired Pneumonia (CAP) and Acute Bacterial Rhinosinusitis (ABRS) in Brazil

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 31 Mar 2025

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At a glance

  • Drugs Amoxicillin/clavulanic acid (Primary)
  • Indications Bacterial infections; Community-acquired pneumonia; Rhinosinusitis
  • Focus Pharmacokinetics
  • Sponsors GlaxoSmithKline; GSK

Most Recent Events

  • 28 Mar 2025 Planned End Date changed from 17 Jan 2024 to 8 Jul 2024.
  • 28 Mar 2025 Planned primary completion date changed from 17 Jan 2024 to 8 Jul 2024.
  • 28 Mar 2025 Planned initiation date changed from 23 Jun 2023 to 14 Oct 2023.

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