A new study reports azithromycin is non-inferior to amoxicillin-clavulanate for resolving exacerbations in children with non-severe bronchiectasis. The study published in the journal The Lancet finds that in some patients, such as those with penicillin hypersensitivity or those likely to have poor adherence, azithromycin provides another option for treating exacerbations, but must be balanced with risk of treatment failure (within a 20% margin), longer exacerbation duration, and the risk of inducing macrolide resistance.
Amoxicillin-clavulanate is the recommended first-line empirical oral antibiotic treatment for non-severe exacerbations in children with bronchiectasis but azithromycin is also often prescribed once-daily dosing.
Vikas Goyal and associates hypothesized that azithromycin is non-inferior to amoxicillin-clavulanate for resolving exacerbations in children with bronchiectasis.
The researchers conducted parallel-group, double-dummy, double-blind, non-inferiority randomized controlled trial which included children aged 1–19 years with radiographically proven bronchiectasis unrelated to cystic fibrosis.
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At the start of an exacerbation, children were randomly assigned to oral suspensions of either amoxicillin-clavulanate (22·5 mg/kg, twice daily) and placebo or azithromycin (5 mg/kg per day) and placebo for 21 days. The primary outcome was the resolution of exacerbation by 21 days in the per-protocol population, with a non-inferiority margin of −20%. The secondary outcomes included the duration of exacerbation, time to next exacerbation, laboratory, respiratory, and quality-of-life measurements, and microbiology.
Key study findings:
- By day 21, 61 (84%) of 73 exacerbations had resolved in the azithromycin group versus 73 (84%) of 87 in the amoxicillin-clavulanate group. The risk difference showed non-inferiority.
- Exacerbations were significantly shorter in the amoxicillin-clavulanate group than in the azithromycin group (median 10 days vs14 days).
- Adverse events were attributed to the trial medication in 17 (21%) of 82 children in the azithromycin group versus 23 (24%) of 97 in the amoxicillin-clavulanate group.
Bronchiectasis is a disease in which there is permanent enlargement of parts of the airways of the lung. Symptoms typically include a chronic cough with mucus production.
For reference log on to https://doi.org/10.1016/S0140-6736(18)31723-9