Dalbavancin for Pediatric 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Drug
Standard of Care
Number of patients with clinical improvement at Day 8
Time frame: Day 8
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
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