NCT01339091

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 Regiment (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 573 (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 proven gram-positive bacterial skin or skin structure infection.

Conditions

• Abscess
• Wound Infection
• Surgical Site Infection
• Cellulitis

Interventions

Type	Name	Description
DRUG	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 Q12 hours). Total duration of therapy is 10-14 days.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2011-04-20
• Last updated: 2014-01-31
• Results posted: 2013-12-25

Locations

91 sites across 8 countries: United States, Canada, Croatia, Georgia, Germany, Poland, Russia, Ukraine