Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia
Year: 2022
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Authors: 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-Lim, Marta Nad, Gabor Simon, Salma Syed, Eva Szabo, Daniel K. Benjamin, Michael Cohen-Wolkowiez, on behalf of the SOLI-PEDS Program
Institutions: Duke Medical Center, Duke Clinical Research Institute, Oregon Health & Science University, Medical University Plovdiv, University of California San Diego, Rady Children's Hospital-San Diego, Research Institute for Tropical Medicine, University of Nevada, Las Vegas, Hospital Universitario La Paz, Pennsylvania State University, Virginia Commonwealth University Medical Center, University of Debrecen, West Visayas State University, Arkansas Children's Hospital, Arkansas Children's Research Institute, Children's National, Philippine General Hospital, University of the Philippines Manila, Nagykanizsai Kanizsai Dorottya Kórház, Fejér Megyei Szent György Egyetemi Oktató Kórház, East Carolina University
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: Multifactorial spatiotemporal analyses to evaluate environmental triggers and patient-level clinical characteristics of severe asthma exacerbations in children, G1468556634, Use of Physiologically-Based PK/PD Models to Streamline Drug Approvals, G221671868, Pharmacokinetics, Pharmacodynamics, and Safety of Methylprednisolone in Neonates on Cardiopulmonary Bypass, G2661008296, G2751190726, G2829770695, G3008453, G5139652136, Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in Children, Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia, G7378573625, Mentoring in Clinical Pharmacology and Early Phase Trials, Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia
OpenAlex ID: W4224231940