83 adults with bronchiectasis and recurrent infective exacerbations
Follow-up
12 months
Primary endpoint
Number of infectious exacerbations
Result
Median exacerbations 0 (IQR 0-1) with azithromycin versus 2 (IQR 1-3) with placebo (p<0.001). At least one exacerbation occurred in 20 of 43 (46%) on azithromycin versus 32 of 40 (80%) on placebo — hazard ratio 0.29 (95% CI 0.16 to 0.51). Gastrointestinal adverse effects affected 40% of the azithromycin group versus 5% on placebo (relative risk 7.44, 95% CI 0.97 to 56.88 for abdominal pain; 8.36, 1.10 to 63.15 for diarrhoea), without need to discontinue treatment.
Secondary endpoints
FEV1, quality of life, macrolide resistance, adverse effects
Among adults with non-CF bronchiectasis, the daily use of azithromycin for 12 months compared with placebo resulted in a lower rate of infectious exacerbations. This could result in better quality of life and might influence survival, although effects on antibiotic resistance need to be considered.
The trial authors, in the published abstract
How it has aged
One of three concordant macrolide trials in bronchiectasis and the basis for long-term azithromycin in frequent exacerbators. As in MACRO and AMAZES, the unresolved cost is macrolide resistance, and non-tuberculous mycobacterial infection must be excluded before starting.
Publications
Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial
Altenburg J, de Graaff CS, Stienstra Y, et al. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA 2013 Mar 27;309(12):1251-9.
Median exacerbations reduced from 2 to 0 over a year
Proportion exacerbating at least once fell from 80% to 46%