APW-RSV-II
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
54.5% male
N = 200
200 patients (91 female, 109 male)
Inclusion criteria: 1-18 months old pediatric patients 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
Patients who developed recurrent wheeze
47
36
47.0 %
35.3 %
23.5 %
11.8 %
0.0 %
Azithromycin
Placebo
No significant difference ↔
No significant difference in 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 1-18 months old pediatric patients hospitalized with RSV bronchiolitis, azithromycin was not superior to placebo with respect to patients who developed recurrent wheeze.
Reference
Avraham Beigelman, Mythili Srinivasan, Charles W Goss et al. Azithromycin to Prevent Recurrent Wheeze Following Severe Respiratory Syncytial Virus Bronchiolitis. NEJM Evid. 2022 Apr;1(4):10.1056/evidoa2100069.
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