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Azithromycin noninferior to amoxicillin-clavulanate for bronchiectasis exacerbation

Elaine Soliven
26 Sep 2018

Azithromycin was noninferior to amoxicillin-clavulanate in resolving respiratory exacerbations among children with bronchiectasis, according to the BEST-2* study presented at ERS 2018.

Researchers gathered data from the three tertiary paediatric hospitals and a general paediatric clinic in Australia and New Zealand and analysed 179 children diagnosed with bronchiectasis who experienced nonsevere exacerbations. Patients were randomized to receive either oral azithromycin 5 mg/kg once daily (n=82, median age 6.4 years) or amoxicillin-clavulanate 22.5 mg/kg twice daily (n=97, median age 6.8 years) for 21 days. [Lancet 2018;doi:10.1016/S0140-6736(18)31723-9]

In the per-protocol population comprising children who had at least one dose of the study drug, both azithromycin and amoxicillin-clavulanate groups showed no significant difference on the incidence rate of resolved exacerbation (83.6 percent vs 83.9 percent, risk difference -0.3 percent, 95 percent confidence interval [CI], -11.8 to 11.1), which was within the 20 percent noninferiority margin.

Similar findings were demonstrated in the intention-to-treat population comprising children who completed treatment, with a comparable incidence rate of resolved exacerbation between the azithromycin and amoxicillin-clavulanate treatment groups (76.8 percent vs 77.3 percent, risk difference, -0.5 percent, 95 percent CI, -12.9 to 11.9).

However, children treated with azithromycin had a longer time to resolution of exacerbation than those treated with amoxicillin-clavulanate (median, 14 vs 10 days for both per-protocol [p=0.014] and intention-to-treat analyses [p=0.013]).

“This finding should be taken into account when choosing antibiotics because bronchiectasis exacerbations can cause substantial morbidity and disease burden, including impaired quality of life and probably child care or school absenteeism for children, and work absence for parents,” said the researchers.

Changes in inflammatory biomarkers, FEV1 percentage predicted, and parent cough-specific quality of life did not differ between the azithromycin and amoxicillin-clavulanate treatment groups.

The most common treatment-related adverse events reported were nausea and diarrhoea, which also occurred at a similar rate in the two treatment groups.

“Although azithromycin might be used cautiously for some patients, such as those with penicillin hypersensitivity or for whom less frequent dosing might improve adherence, amoxicillin-clavulanate remains the first-choice empirical antibiotic … for treating nonsevere exacerbations of bronchiectasis in children,” the researchers said.

Amoxicillin-clavulanate was used as the reference treatment because in Australia and New Zealand, it is the recommended first-line antibiotic for outpatient management of children with bronchiectasis when lower airway specimens are unavailable,” they said, recommending further research in other populations to validate these findings.

 

*BEST-2: Bronchiectasis Exacerbation Study (Study 2)

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