A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthetic Hip or Knee Joint Caused by Staphylococci.

Trial Profile

A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthetic Hip or Knee Joint Caused by Staphylococci.

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Jan 2016

At a glance

  • Drugs Daptomycin (Primary) ; Flucloxacillin; Nafcillin; Oxacillin; Teicoplanin; Vancomycin
  • Indications Osteomyelitis; Staphylococcal infections
  • Focus Adverse reactions
  • Sponsors Cubist Pharmaceuticals
  • Most Recent Events

    • 17 Aug 2013 New source identified and integrated (European Clinical Trials Database; EudraCT2006-005453-30).
    • 10 May 2011 Results presented at the 21st European Congress of Clinical Microbiology and Infectious Diseases and the 27th International Congress of Chemotherapy.
    • 14 Jul 2010 Cubist reported results in a media release and plans to submit these results as a late breaker to a fall 2010 infectious disease conference.
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