Clinical Trials Directory

Trials / Completed

CompletedNCT02814916

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
199 (actual)
Sponsor
AbbVie · Industry
Sex
All
Age
0 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDalbavancinDalbavancin was administered intravenously over 30 (± 5) minutes.
DRUGVancomycinVancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
DRUGOxacillinOxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
DRUGFlucloxacillinFlucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
DRUGCefadroxilCefadroxil was administered orally every 12 hours.
DRUGClindamycinClindamycin was administered orally every 8 hours.

Timeline

Start date
2017-03-30
Primary completion
2024-01-01
Completion
2024-01-01
First posted
2016-06-28
Last updated
2024-09-19
Results posted
2024-09-19

Locations

84 sites across 20 countries: United States, Argentina, Belarus, Brazil, Bulgaria, Chile, Colombia, Georgia, Greece, Guatemala, Latvia, Lithuania, Mexico, Panama, Poland, Romania, Russia, South Africa, Spain, Ukraine

Regulatory

Source: ClinicalTrials.gov record NCT02814916. Inclusion in this directory is not an endorsement.