NCT02127970

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

A Phase 3b, Double-Blind, Multicenter, Randomized Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

Conditions

• Abscess
• Wound Infection
• Surgical Site Infection
• Cellulitis

Interventions

Type	Name	Description
DRUG	Dalbavancin	Dalbavancin IV infusion over 30 minutes.
DRUG	Dalbavancin-matching Placebo	Dalbavancin-matching placebo IV infusion over 30 minutes.

Timeline

• Start date: 2014-04-18
• Primary completion: 2015-03-11
• Completion: 2015-03-11
• First posted: 2014-05-01
• Last updated: 2018-09-28
• Results posted: 2018-08-14

Locations

78 sites across 12 countries: United States, Bulgaria, Croatia, Estonia, Georgia, Hungary, Latvia, Romania, Russia, Serbia, South Africa, Ukraine