NCT01431339

Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regimen (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 739 (actual)
• Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.

Conditions

• Abscess
• Wound Infection
• Surgical Site Infection
• Cellulitis

Interventions

Type	Name	Description
DRUG	IV Dalbavancin	IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
DRUG	Vancomycin/Linezolid	IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2011-09-09
• Last updated: 2014-02-12
• Results posted: 2014-02-12

Locations

137 sites across 14 countries: United States, Bulgaria, Estonia, Hungary, Israel, Latvia, Lithuania, Romania, Russia, Slovakia, South Africa, South Korea, Taiwan, Ukraine