NCT01811732

Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

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: Phase 3
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

Detailed description

The efficacy and safety of delafloxacin, compared to that of vancomycin plus aztreonam, will be evaluated in a population of patients with acute bacterial skin and soft tissue infections (ABSSSI), including major cutaneous abscesses, wound infections, cellulitis/erysipelas, and burn-related infections.

Conditions

• Skin and Subcutaneous Tissue Bacterial Infections

Interventions

Type	Name	Description
DRUG	Delafloxacin	Delafloxacin
DRUG	Vancomycin	Vancomycin
DRUG	Aztreonam	Aztreonam
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-03-15
• Last updated: 2017-09-27
• Results posted: 2017-08-24

Locations

50 sites across 7 countries: United States, Croatia, Israel, Latvia, Russia, Spain, Ukraine