NCT01984684

Delafloxacin vs 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 + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.

Detailed description

The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of skin and nearby tissue infections compared with a combination of other antibiotics, vancomycin and aztreonam.

Conditions

• Skin and Subcutaneous Tissue Bacterial Infections
• Skin Structures and Soft Tissue Infections

Interventions

Type	Name	Description
DRUG	delafloxacin
DRUG	vancomycin
DRUG	aztreonam

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2013-11-15
• Last updated: 2017-11-17
• Results posted: 2017-08-28

Locations

94 sites across 16 countries: United States, Argentina, Brazil, Bulgaria, Chile, Estonia, Georgia, Hungary, Latvia, Mexico, Moldova, Peru, Romania, Slovakia, South Korea, Taiwan