TY - JOUR
T1 - Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia
AU - Lang, Jason E.
AU - Hornik, Christoph P.
AU - Elliott, Carrie
AU - Silverstein, Adam
AU - Hornik, Chi
AU - Al-Uzri, Amira
AU - Bosheva, Miroslava
AU - Bradley, John S.
AU - Borja-Tabora, Charissa Fay Corazon
AU - Di John, David
AU - Mendez Echevarria, Ana
AU - Ericson, Jessica E.
AU - Friedel, David
AU - Gonczi, Ferenc
AU - Isidro, Marie Grace Dawn
AU - James, Laura P.
AU - Kalocsai, Krisztina
AU - Koutroulis, Ioannis
AU - Laki, Istvan
AU - Ong-Lim, Anna Lisa T.
AU - Nad, Marta
AU - Simon, Gabor
AU - Syed, Salma
AU - Szabo, Eva
AU - Benjamin, Daniel K.
AU - Cohen-Wolkowiez, Michael
N1 - Publisher Copyright:
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - 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.
AB - 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.
KW - macrolide
KW - pediatric
KW - pneumonia
KW - solithromycin
UR - http://www.scopus.com/inward/record.url?scp=85131632184&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85131632184&partnerID=8YFLogxK
U2 - 10.1097/INF.0000000000003559
DO - 10.1097/INF.0000000000003559
M3 - Article
C2 - 35675525
AN - SCOPUS:85131632184
SN - 0891-3668
VL - 41
SP - 556
EP - 562
JO - Pediatric Infectious Disease Journal
JF - Pediatric Infectious Disease Journal
IS - 7
ER -