CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 199 enrolled
Drug / intervention
Dalbavancin +5 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.

Search/NCT02814916
NCT02814916Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

AbbVie·interventional·Posted Jun 28, 2016·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating Dalbavancin, Vancomycin, and 4 other interventions for Methicillin-Resistant Staphylococcus Aureus and 2 related conditions. Completed, enrolled 199 participants across 84 sites in 20 countries.

Detailed Summary

To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMethicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
CountriesArgentina, Belarus, Brazil, Bulgaria, Chile, Colombia, Georgia, Greece, Guatemala, Latvia, Lithuania, Mexico, Panama, Poland, Romania, Russia, South Africa, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 28, 2016
Enrollment StartMar 30, 2017
Primary CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 10.0 years ago

Interventions

Dalbavancindrug

Dalbavancin was administered intravenously over 30 (± 5) minutes.

Vancomycindrug

Vancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

Oxacillindrug

Oxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

Flucloxacillindrug

Flucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

Cefadroxildrug

Cefadroxil was administered orally every 12 hours.

Clindamycindrug

Clindamycin was administered orally every 8 hours.