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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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At a glance

  • Drugs Delafloxacin (Primary) ; Aztreonam; Vancomycin
  • Indications Abscess; Bacterial skin diseases; Burn infections; Cellulitis; Erysipelas; Gram-negative infections; Skin and soft tissue infections; Wound infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PROCEED
  • Sponsors Melinta Therapeutics
  • Most Recent Events

    • 09 Jul 2020 Results of post hoc analysis published in Menarini Ricerche Media Release.
    • 09 Jul 2020 According to a Menarini Ricerche media release, a post hoc analysis of pooled data from Phase 3 ABSSSI trials are included in the abstract book of the 30th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
    • 08 Apr 2019 Results of pooled analysis from two phase III trials (NCT01984684, NCT01811732) assessing efficacy data across the Phase III ABSSSI studies, published in the Clinical Infectious Diseases.
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