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
Phase of Trial: Phase III
Latest Information Update: 19 Jun 2017
At a glance
- Drugs Delafloxacin (Primary) ; Aztreonam; Vancomycin
- Indications Abscess; Bacterial skin diseases; Burn infections; Cellulitis; Erysipelas; Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections; Skin infections; Wound infections
- Focus Registrational; Therapeutic Use
- Acronyms PROCEED
- Sponsors Melinta Therapeutics
- 19 Jun 2017 According to a Melinta Therapeutics media release, Based on the data of this and another phase 3 study (CTP70051731), 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History