Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia.

ABSTRACT:

Background

Solithromycin is a new macrolide-ketolide antibiotic with potential effectiveness in pediatric community-acquired bacterial pneumonia (CABP). Our objective was to evaluate its safety and effectiveness in children with CABP.

Methods

This phase 2/3, randomized, open-label, active-control, multicenter study randomly assigned solithromycin (capsules, suspension or intravenous) or an appropriate comparator antibiotic in a 3:1 ratio (planned n = 400) to children 2 months to 17 years of age with CABP. Primary safety endpoints included treatment-emergent adverse events (AEs) and AE-related drug discontinuations. Secondary effectiveness endpoints included clinical improvement following treatment without additional antimicrobial therapy.

Results

Unrelated to safety,

SUBMITTER: Lang JE 

PROVIDER: S-EPMC9199591 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature