Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia

Jason E. Lang, Christoph P. Hornik, Carrie Elliott, Adam Silverstein, Chi Hornik, Amira Al-Uzri, Miroslava Bosheva, John S. Bradley, Charissa Fay Corazon Borja-Tabora, David Di John, Ana Mendez Echevarria, Jessica E. Ericson, David Friedel, Ferenc Gonczi, Marie Grace Dawn Isidro, Laura P. James, Krisztina Kalocsai, Ioannis Koutroulis, Istvan Laki, Anna Lisa T. Ong-LimMarta Nad, Gabor Simon, Salma Syed, Eva Szabo, Daniel K. Benjamin, Michael Cohen-Wolkowiez

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1 Scopus citations

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, 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.

Original languageEnglish (US)
Pages (from-to)556-562
Number of pages7
JournalPediatric Infectious Disease Journal
Volume41
Issue number7
DOIs
StatePublished - Jul 1 2022

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

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