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Published on: April 4, 2019
Azithromycin to Prevent Recurrent Wheeze Following Severe Respiratory Syncytial Virus Bronchiolitis
Avraham Beigelman1,2, Mythili Srinivasan3, Charles W Goss4
1Division of Allergy and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis.
Insights
Azithromycin treatment for severe respiratory syncytial virus (RSV) bronchiolitis in infants did not prevent recurrent wheezing. The study found no benefit in using azithromycin to reduce post-RSV wheeze in children.
Area of Science:
- Pediatric Pulmonology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Severe respiratory syncytial virus (RSV) bronchiolitis in early life is a known risk factor for developing childhood asthma.
- Azithromycin's anti-inflammatory properties were investigated for potential to mitigate airway inflammation during RSV bronchiolitis.
Purpose of the Study:
- To evaluate the efficacy of azithromycin in reducing the occurrence of recurrent wheeze after severe RSV bronchiolitis.
- To determine if early-life azithromycin treatment impacts the long-term risk of post-RSV wheezing.
Main Methods:
- A prospective, single-center, double-blind, placebo-controlled study enrolled 200 infants (1-18 months) hospitalized with RSV bronchiolitis.
- Participants received either oral azithromycin (14 days total) or a placebo, with randomization stratified by prior antibiotic use.
- The primary outcome measured was the incidence of recurrent wheeze (≥3 episodes) over a 2-4 year follow-up period.
Main Results:
- Azithromycin demonstrated biologic activity, evidenced by lower nasal wash interleukin-8 levels at day 14 (P<0.01).
- However, azithromycin did not significantly reduce the risk of post-RSV recurrent wheeze (47% vs. 36%; adjusted hazard ratio, 1.45; P=0.11).
- A potential increased risk of recurrent wheeze was observed in antibiotic-naïve infants treated with azithromycin (hazard ratio, 1.79).
Conclusions:
- Fourteen-day azithromycin therapy during acute severe RSV bronchiolitis did not decrease the occurrence of recurrent wheeze in the subsequent 2-4 years.
- Current data suggest no preventative benefit of azithromycin for recurrent wheeze in children following RSV infection.
- Further investigation may be warranted for specific subgroups, considering the signal in antibiotic-naïve infants.
Background:
Early-life severe respiratory syncytial virus (RSV) bronchiolitis is a risk factor for childhood asthma. Because azithromycin may attenuate airway inflammation during RSV bronchiolitis, we evaluated whether it would reduce the occurrence of post-RSV recurrent wheeze.
Methods:
We prospectively enrolled 200 otherwise healthy 1- to 18-month-old children hospitalized with RSV bronchiolitis in this single-center, double-blind, placebo-controlled study and randomly assigned them to receive oral azithromycin (10 mg/kg daily for 7 days, followed by 5 mg/kg daily for 7 days) or placebo. Randomization was stratified by recent open-label antibiotic use. The primary outcome was the occurrence of recurrent wheeze, defined as a third episode of post-RSV wheeze over the following 2 to 4 years.
Results:
As an indication of the biologic activity of azithromycin, nasal wash interleukin-8 levels, at day 14 after randomization, were lower among azithromycin-treated participants (P<0.01). Despite evidence of biologic activity, azithromycin did not reduce the risk of post-RSV recurrent wheeze (47% in the azithromycin group vs. 36% in the placebo group; adjusted hazard ratio, 1.45; 95% confidence interval [CI], 0.92 to 2.29; P=0.11). Azithromycin also did not modify the risk of recurrent wheeze among participants already receiving other antibiotic treatment at the time of enrollment (hazard ratio, 0.94; 95% CI, 0.43 to 2.07). There was a potential signal among antibiotic-naïve participants who received azithromycin to have an increased risk of recurrent wheeze (hazard ratio, 1.79; 95% CI, 1.03 to 3.1).
Conclusions:
Azithromycin therapy for 14 days during acute severe RSV bronchiolitis did not reduce recurrent wheeze occurrence over the following 2 to 4 years. Our data suggest no benefit of azithromycin administration with the goal of preventing recurrent wheeze in later life. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT02911935.).
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