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A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be Due to Gram-Positive Organisms

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Trial Profile

A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be Due to Gram-Positive Organisms

Status: Withdrawn prior to enrolment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

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Dalbavancin (Primary) ; Cefazolin; Nafcillin; Oxacillin; Vancomycin
  • Indications Bacterial infections; Osteomyelitis
  • Focus Therapeutic Use
  • Sponsors Durata Therapeutics

Most Recent Events

  • 22 Sep 2016 Status changed from not yet recruiting to withdrawn prior to enrolment.
  • 15 Jun 2016 The trial was prematurely ended in Spain.
  • 26 Feb 2016 Planned initiation date changed from 1 Mar 2015 to 1 Mar 2016, according to ClinicalTrials.gov record.

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