Azithromycin of little benefit in preschool-age children with acute wheezing

Azithromycin appears to only be as good as placebo in the treatment of preschool-age children presenting to the emergency department (ED) with moderate-to-severe acute wheezing, according to a study.

The study included 840 paediatric patients between 18 and 59 months of age who presented to an ED with a moderate-to-severe episode of wheezing, among whom 521 tested positive for pathogenic bacteria. These patients were randomly assigned to receive azithromycin once daily at a dose of 12 mg per kilogram of body weight or matching placebo for 5 days.

Researchers calculated the sum of scores on the Asthma Flare-up Diary for Young Children (ADYC) over 5 days as the primary endpoint. Scores ranged from 5 to 35, with higher scores indicating more severe wheezing-related symptoms. ADYC scores were evaluated separately in patients who tested positive for pathogenic bacteria (the positive cohort) and in those who tested negative (the negative cohort).

Secondary outcomes included length of stay in the ED, length of hospital stay, and return ED visits or hospitalizations within 72 h. Bacterial clearance and antimicrobial resistance were assessed at follow-up visits 1 to 3 weeks after randomization.

The trial was discontinued prematurely due to futility. ADYC scores did not significantly differ between the azithromycin and placebo groups in the positive cohort (median, 9.59 vs 9.72; p=0.70) and the negative cohort (median, 9.30 vs 9.10; p=0.69).

Bacterial clearance in the positive cohort occurred in 58.7 percent of azithromycin-treated patients and in 11.4 percent of those who received placebo.

Results for secondary outcomes, the number of patients who developed bacterial resistance, and the incidence of adverse events were similar between the azithromycin and placebo groups.