NCT02344511

Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis

A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be Due to Gram-Positive Organisms

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Durata Therapeutics International BV (an Affiliate of Actavis, Inc.) · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

Dalbavancin for Pediatric Osteomyelitis

Detailed description

A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms.

Conditions

• Osteomyelitis

Interventions

Type	Name	Description
DRUG	Dalbavancin	Drug
DRUG	cefazolin, nafcillin, oxacillin or vancomycin	Standard of Care

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-10-01
• Completion: 2019-04-01
• First posted: 2015-01-26
• Last updated: 2016-09-23