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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2017

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

    • 19 Jun 2017 According to a Melinta Therapeutics media release, based on the data from this and another phase 3 study (CTP700230608), the U.S. Food and Drug Administration (FDA) has approved Baxdela (delafloxacin), indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
    • 01 Jun 2017 According to a Melinta Therapeutics media release, data from this study will be presented at ASM Microbe 2017.
    • 02 May 2017 Pooled analysis from a subgroup of patients in this trial presented at the Society of Hospital Medical Meeting, according to a Melinta Therapeutics media release.
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