Effect of Once-Weekly Azithromycin vs Placebo in Children Wi
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HIV-associated chronic lung disease (HCLD) in children is associated with small airways disease, is common despite antiretroviral therapy (ART), and is associated with substantial morbidity. Azithromycin has antibiotic and immunomodulatory activity and may be effective in treating HCLD through reducing respiratory tract infections and inflammation.

A Study was conducted to determine whether prophylactic azithromycin is effective in preventing worsening of lung function and in reducing acute respiratory exacerbations (AREs) in children with HCLD taking ART.

This double-blind, placebo-controlled, randomized clinical trial (BREATHE), included 12 months of follow-up at outpatient HIV clinics. Participants were randomized 1:1 to intervention or placebo, and participants and study personnel were blinded to treatment allocation. Participants included children aged 6 to 19 years with perinatally acquired HIV and HCLD (defined as forced expiratory volume in 1 second [FEV1] z score less than -1) who were taking ART for 6 months or longer.

All outcomes were prespecified. The primary outcome was the mean difference in FEV1- z score using intention-to-treat analysis for participants seen at end line. Secondary outcomes included AREs, all-cause hospitalizations, mortality, and weight-for-age z score.

Results:
A total of 347 individuals were randomized, 174 to the azithromycin group and 173 to the placebo group;
--162 participants in the azithromycin group and 146 placebo group participants had a primary outcome available and were analyzed.
--The mean difference in FEV1? z score was 0.06 higher in the azithromycin group than in the placebo group, a nonsignificant difference.
--The rate of AREs was 12.1 events per 100 person-years in the azithromycin group and 24.7 events per 100 person-years in the placebo groups.
--The hospitalization rate was 1.3 events per 100 person-years in the azithromycin group and 7.1 events per 100 person-years in the placebo groups, but the difference was not significant.
--3 deaths occurred, all in the placebo group.
--The mean weight-for-age z score was 0.03 higher in the azithromycin group than in the placebo group, although the difference was not significant. There were no drug-related severe adverse events.

In this randomized clinical trial specifically addressing childhood HCLD, once-weekly azithromycin did not improve lung function or growth but was associated with reduced AREs; the number of hospitalizations was also lower in the azithromycin group.

Source: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774283
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