A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2018

At a glance

  • Drugs Delafloxacin (Primary) ; Delafloxacin (Primary) ; Aztreonam; Vancomycin
  • Indications Bacterial infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PROCEED
  • Sponsors Melinta Therapeutics
  • Most Recent Events

    • 08 Mar 2018 According to a Melinta Therapeutics media release, company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for delafloxacin for the treatment of adult patients with acute bacterial skin and skin structure infections, based on results of this and other trial (700230608).
    • 06 Mar 2018 Results published in the Clinical Infectious Diseases Journal.
    • 08 Oct 2017 Results (n=1492) of pooled analysis of this and other phase III trial assessing safety presented at the IDWeek 2017.
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