At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 698 enrolled
Drug / intervention
Dalbavancin +1 moredrug
Likely dose
Not stated in 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.
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
Durata Therapeutics Inc., an affiliate of Allergan plc·interventional·Posted May 1, 2014·Updated Sep 28, 2018
In Brief
A Phase 3 clinical trial evaluating Dalbavancin and Dalbavancin-matching Placebo for Abscess and 3 related conditions. Completed, enrolled 698 participants across 78 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbscess, Wound Infection, Surgical Site Infection, Cellulitis
CountriesBulgaria, Croatia, Estonia, Georgia, Hungary, Latvia, Romania, Russia, Serbia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedMay 2014
Primary CompletionMar 2015
TodayJul 2026
First PostedMay 1, 2014
Enrollment StartApr 18, 2014
Primary CompletionMar 11, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.2 years ago
Interventions
Dalbavancindrug
Dalbavancin IV infusion over 30 minutes.
Dalbavancin-matching Placebodrug
Dalbavancin-matching placebo IV infusion over 30 minutes.