6/28/23, 12:43 AM APW-RSV-II Pathway Feedback Search Clinical Topics Home Studies APW RSV II APW RSV II Disease Bronchiolitis Trial question What is the role of azithromycin in children hospitalized with recurrent syncytial virus bronchiolitis? Study design Single center Double blinded RCT Population Characteristics of study participants 45.5% female N = 200 54.5% male 200 patients (91 female, 109 male) Inclusion criteria: healthy 1 to 18 months old children hospitalized with RSV bronchiolitis Key exclusion criteria: prematurity; history or presence of other significant diseases; history of previous wheeze or previous treatment with albuterol; significant developmental delay; failure to thrive Interventions N=101 azithromycin (oral suspension of 10 mg/kg daily for 7 days, followed by 5 mg/kg daily for 7 days) N=99 placebo (placebo suspension) Primary outcome https://web.pathway.md/studies/recYCoNyA01KN09Cm 1/2 6/28/23, 12:43 AM APW-RSV-II Pathway Percentage of patients who developed recurrent wheeze 47.0 % 47 36 35.3 % 23.5 % 11.8 % No significant difference 0.0 % Azithromycin Placebo No significant difference in the percentage of patients who developed recurrent wheeze (47% vs. 36%; HR 1.45, 95% CI 0.92 to 2.29) Secondary outcomes No significant difference in the incidence of respiratory symptoms (26.2 days/year vs. 22.2 days/year; RR 1.18, 95% CI 0.86 to 1.62) No significant difference in the incidence of albuterol use (4 days/year vs. 3.3 days/year; RR 1.22, 95% CI 0.6 to 2.48) No significant difference in asthma diagnosis by the end of data collection (15.6% vs. 8.7%; HR 1.95, 95% CI 0.83 to 4.61) Safety outcomes No significant difference in serious adverse events. Conclusion In healthy 1 to 18 months old children hospitalized with RSV bronchiolitis, azithromycin was not superior to placebo with respect to the percentage of patients who developed recurrent wheeze. Reference Avraham Beigelman, M.D., Mythili Srinivasan et al. Azithromycin to Prevent Recurrent Wheeze Following Severe Respiratory Syncytial Virus Bronchiolitis. NEJM Evid. 2022;1(4). Open reference URL https://web.pathway.md/studies/recYCoNyA01KN09Cm 2/2