NCT00719810

Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

A Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of RX 3341 Compared With Tigecycline for the Treatment of Complicated Skin and Skin Structure Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.

Conditions

• Skin Structure Infections
• Bacterial Skin Diseases
• Staphylococcal Skin Infections

Interventions

Type	Name	Description
DRUG	delafloxacin	300 mg intravenous every 12 hours
DRUG	delafloxacin	450 mg intravenous every 12 hours
DRUG	tigecycline	100 mg then 50 mg intravenous tigecycline every 12 hours

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-07-22
• Last updated: 2014-07-14
• Results posted: 2010-02-03

Locations

14 sites across 2 countries: United States, Puerto Rico