Solithromycin safe, effective in paediatric community-acquired bacterial pneumonia
Treatment with intravenous or oral solithromycin is well-tolerated and leads to clinical improvement in most children and adolescents with community-acquired bacterial pneumonia (CABP), results of a recent study have shown.
In this phase II/III, randomized, open-label, active-control, multicentre study, children with CABP aged 2‒17 years were randomly assigned to receive either solithromycin (capsules, suspension, or intravenous) or an appropriate comparator antibiotic in a 3:1 ratio (planned n=400).
Treatment-emergent adverse events (AEs) and AE-related drug discontinuations were the primary safety endpoints. Secondary effectiveness endpoint was clinical improvement following treatment without additional antimicrobial therapy.
The trial was stopped prior to completion, but the reason was not related to safety. Before discontinuation, 97 participants were randomized to solithromycin (n=73) or comparator (n=24). Treatment-emergent AE occurred in 24 children (34 percent, 95 percent confidence interval [CI], 23‒47) in the solithromycin group and seven (29 percent, 95 percent CI, 13‒51) in the comparator group.
The most common AEs associated with solithromycin were infusion site pain and elevated liver enzymes. Treatment was stopped due to AEs in three patients (4.3 percent) in the solithromycin group and one (4.2 percent) in the comparator group.
Forty children (65 percent, 95 percent CI, 51‒76) on solithromycin achieved clinical improvement on the last day of treatment compared with 17 (81 percent, 95 percent CI, 58‒95) in the comparator group. The number of patients achieving clinical cure was similar between solithromycin (60 percent, 95 percent CI, 47‒72) and comparator groups (68 percent, 95 percent CI, 43‒87).
“Solithromycin is a new macrolide-ketolide antibiotic with potential effectiveness in paediatric CABP,” the investigators said.