Clinical Trial: Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: 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
Brief Summary: Dalbavancin for Pediatric Osteomyelitis
Detailed Summary: 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.
Sponsor: Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)
Current Primary Outcome: Number of patients with clinical improvement at Day 8 [ Time Frame: Day 8 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of clinical responders [ Time Frame: Day 8 ]
- Average reduction in C-reactive Protein (CRP) relative to the highest value [ Time Frame: Day 8 ]
- Number of clinical responders by pathogen [ Time Frame: Day 8 ]
- Number of Participants with Adverse Events [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Durata Therapeutics Inc., an affiliate of Allergan plc
Dates:
Date Received: January 10, 2015
Date Started: March 2016
Date Completion: April 2019
Last Updated: September 22, 2016
Last Verified: September 2016
