CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 573 enrolled
Drug / intervention
Dalbavancin +1 moredrug
Likely dose
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/NCT01339091
NCT01339091Phase 3Completed
CompareCT.gov

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

Durata Therapeutics Inc., an affiliate of Allergan plc·interventional·Posted Apr 20, 2011·Updated Jan 31, 2014

In Brief

A Phase 3 clinical trial evaluating Dalbavancin and Vancomycin / Linezolid for Abscess and 3 related conditions. Completed, enrolled 573 participants across 91 sites in 8 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 proven gram-positive bacterial skin or skin structure infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbscess, Wound Infection, Surgical Site Infection, Cellulitis
CountriesCanada, Croatia, Georgia, Germany, Poland, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2011
Enrollment StartMar 1, 2011
Primary CompletionSep 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.2 years ago

Interventions

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 Q12 hours). Total duration of therapy is 10-14 days.