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A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia Including SA Right-sided Infective Endocarditis

Trial Profile

A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia Including SA Right-sided Infective Endocarditis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2019

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At a glance

  • Drugs Telavancin (Primary) ; Cefazolin; Daptomycin; Penicillins; Vancomycin
  • Indications Bacteraemia; Bacterial endocarditis; Staphylococcal infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Cumberland Pharmaceuticals; Theravance Biopharma
  • Most Recent Events

    • 27 Feb 2018 Status changed from recruiting to discontinued following recent interim analysis conducted by independent review committee and company-wide review of investment priorities Committee concluded the study is underpowered and therefore unlikely to achieve the primary study objective without a significant increase in study size beyond the planned enrollment of 250 patients, according to a Theravance Biopharma media release.
    • 08 Mar 2017 Planned End Date changed from 1 Oct 2017 to 1 May 2018.
    • 08 Mar 2017 Planned primary completion date changed from 1 Jul 2017 to 1 Mar 2018.
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