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A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms

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Trial Profile

A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2023

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At a glance

  • Drugs Daptomycin (Primary) ; Amoxicillin; Ceftriaxone; Flucloxacillin; Nafcillin; Sulfamethoxazole; Teicoplanin; Trimethoprim; Vancomycin
  • Indications Gram-positive infections; Osteomyelitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Cubist Pharmaceuticals; Merck Sharp & Dohme

    • Most Recent Events

    • 16 Jun 2020 Primary endpoint (Percentage of participants with clinical improvement in the 3 general categories of Pain, Inflammation, and Limb Function based on the Investigators overall assessment of severity of each of the symptom categories.)has not been met, as per Results published in the Pediatric Infectious Disease Journal
    • 16 Jun 2020 Results published in the Pediatric Infectious Disease Journal
    • 02 Jan 2017 Status changed from active, no longer recruiting to completed.

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