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

Journal Article (Journal Article;Multicenter Study)

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, the sponsor stopped the trial prior to completion. Before discontinuation, 97 participants were randomly assigned to solithromycin (n = 73) or comparator (n = 24). There were 24 participants (34%, 95% CI, 23%-47%) with a treatment-emergent AE in the solithromycin group and 7 (29%, 95% CI, 13%-51%) in the comparator group. Infusion site pain and elevated liver enzymes were the most common related AEs with solithromycin. Study drug was discontinued due to AEs in 3 subjects (4.3%) in the solithromycin group and 1 (4.2%) in the comparator group. Forty participants (65%, 95% CI, 51%-76%) in the solithromycin group achieved clinical improvement on the last day of treatment versus 17 (81%, 95% CI, 58%-95%) in the comparator group. The proportion achieving clinical cure was 60% (95% CI, 47%-72%) and 68% (95% CI, 43%-87%) for the solithromycin and comparator groups, respectively. CONCLUSIONS: Intravenous and oral solithromycin were generally well-tolerated and associated with clinical improvement in the majority of participants treated for CABP.

Full Text

Duke Authors

Cited Authors

  • Lang, JE; Hornik, CP; Elliott, C; Silverstein, A; Hornik, C; Al-Uzri, A; Bosheva, M; Bradley, JS; Borja-Tabora, CFC; Di John, D; Mendez Echevarria, A; Ericson, JE; Friedel, D; Gonczi, F; Isidro, MGD; James, LP; Kalocsai, K; Koutroulis, I; Laki, I; Ong-Lim, ALT; Nad, M; Simon, G; Syed, S; Szabo, E; Benjamin, DK; Cohen-Wolkowiez, M; SOLI-PEDS Program,

Published Date

  • July 1, 2022

Published In

Volume / Issue

  • 41 / 7

Start / End Page

  • 556 - 562

PubMed ID

  • 35675525

Pubmed Central ID

  • PMC9199591

Electronic International Standard Serial Number (EISSN)

  • 1532-0987

Digital Object Identifier (DOI)

  • 10.1097/INF.0000000000003559


  • eng

Conference Location

  • United States