Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 Jul 1;41(7):556-562.
doi: 10.1097/INF.0000000000003559. Epub 2022 Jun 7.

Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia

Jason E Lang  1   2 , Christoph P Hornik  1   2 , Carrie Elliott  2 , Adam Silverstein  2 , Chi Hornik  1   2 , Amira Al-Uzri  3 , Miroslava Bosheva  4 , John S Bradley  5 , Charissa Fay Corazon Borja-Tabora  6 , David Di John  7 , Ana Mendez Echevarria  8 , Jessica E Ericson  9 , David Friedel  10 , Ferenc Gonczi  11 , Marie Grace Dawn Isidro  12 , Laura P James  13 , Krisztina Kalocsai  14 , Ioannis Koutroulis  15 , Istvan Laki  16 , Anna Lisa T Ong-Lim  17 , Marta Nad  18 , Gabor Simon  19 , Salma Syed  20 , Eva Szabo  21 , Daniel K Benjamin Jr  1   2 , Michael Cohen-Wolkowiez  1   2 ; SOLI-PEDS Program
Affiliations
Clinical Trial

Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia

Jason E Lang et al. Pediatr Infect Dis J. .

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.

PubMed Disclaimer

Conflict of interest statement

J.E.L. receives salary support for research from the nonprofit organization Thrasher Research Fund (www.thrasherresearch.org), the American Lung Association, National Heart Lung and Blood Institute (NHLBI) (HL145415), University of Arkansas for Medical Sciences and Regeneron Pharmaceuticals; C.P.H. receives salary support for research from National Institute for Child Health and Human Development (NICHD) (1K23HD090239), the National Heart Lung and Blood Institute (NHLBI) (R61/R33HL147833), the US Food and Drug Administration (1R01-FD006099, PI Laughon; and 5U18-FD006298, PI: Benjamin), the U.S. government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (https://dcri.org/about-us/conflict-of-interest/). M.C.-W. receives support for research from the National Institutes of Health (1R01-HD076676-01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), Federal Drug Administration (5U18-FD006298), and industry for drug development in adults and children. The other authors have no conflicts of interest to disclose. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Figures

Figure 1.
Figure 1.
Profile of participants.
See this image and copyright information in PMC

References

    1. Haq IJ, Battersby AC, Eastham K, McKean M. Community acquired pneumonia in children. BMJ. 2017;356:j686. - PubMed
    1. Michelow IC, Olsen K, Lozano J, Rollins NK, Duffy LB, Ziegler T, et al. Epidemiology and clinical characteristics of community-acquired pneumonia in hospitalized children. Pediatrics. 2004;113(4):701–7. - PubMed
    1. Heiskanen-Kosma T, Korppi M, Jokinen C, Kurki S, Heiskanen L, Juvonen H, et al. Etiology of childhood pneumonia: serologic results of a prospective, population-based study. Pediatr Infect Dis J. 1998;17(11):986–91. - PubMed
    1. Principi N, Esposito S, Blasi F, Allegra L, Mowgli study g. Role of Mycoplasma pneumoniae and Chlamydia pneumoniae in children with community-acquired lower respiratory tract infections. Clin Infect Dis. 2001;32(9):1281–9. - PubMed
    1. Ranganathan SC, Sonnappa S. Pneumonia and other respiratory infections. Pediatr Clin North Am. 2009;56(1):135–56, xi. - PMC - PubMed

Publication types

MeSH terms