CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 739 enrolled
Drug / intervention
IV Dalbavancin +1 moredrug
Likely dose
IV Dalbavancin 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01431339
NCT01431339Phase 3Completed
CompareCT.gov

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

Durata Therapeutics Inc., an affiliate of Allergan plc·interventional·Posted Sep 9, 2011·Updated Feb 12, 2014

In Brief

A Phase 3 clinical trial evaluating IV Dalbavancin and Vancomycin/Linezolid for Abscess and 3 related conditions. Completed, enrolled 739 participants across 137 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbscess, Wound Infection, Surgical Site Infection, Cellulitis
CountriesBulgaria, Estonia, Hungary, Israel, Latvia, Lithuania, Romania, Russia, Slovakia, South Africa, South Korea, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2011
Enrollment StartJul 1, 2011
Primary CompletionNov 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.8 years ago

Interventions

IV Dalbavancindrug

IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8

Vancomycin/Linezoliddrug

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