A Phase 3, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Brilacidin versus IV Vancomycin Followed by Optional PO Linezolid for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Trial Profile

A Phase 3, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Brilacidin versus IV Vancomycin Followed by Optional PO Linezolid for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Planning
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2016

At a glance

  • Drugs Brilacidin (Primary)
  • Indications Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections; Streptococcal infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Cellceutix
  • Most Recent Events

    • 26 Feb 2016 According to a Cellceutix media release, the company has submitted a Special Protocol Assessment (SPA) request, along with a final protocol to FDA, for a phase 3 clinical trial of Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
    • 09 Feb 2016 According to a Cellceutix media release, the company will be submitting an SPA request for the phase III trials of brilacidin for the treatment of acute bacterial skin and skin structure infection (ABSSSI) caused by Gram-positive bacteria. An interim analysis will be performed as part of the first study.
    • 20 Jul 2015 According to Cellceutix media release, this study includes two study- first study will include an interim analysis after a portion of the patients has been enrolled.
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