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A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

Trial Profile

A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jan 2024

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At a glance

  • Drugs Dalbavancin (Primary) ; Aztreonam; Cefadroxil; Clindamycin; Flucloxacillin; Metronidazole; Metronidazole; Oxacillin; Vancomycin
  • Indications Bacterial infections; Gram-positive infections; Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Sponsors AbbVie; Allergan; Durata Therapeutics
  • Most Recent Events

    • 16 Jan 2024 Status changed from recruiting to completed.
    • 04 Jul 2023 This trial has been discontinued in Spain, according to the European Clinical Trials Database record.
    • 07 Dec 2022 Results assessing the safety and descriptive efficacy data of dalbavancin and active comparator the treatment of acute bacterial skin and skin structure infections in children, published in the Pediatric Infectious Disease Journal.
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