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).
Secondary endpoints
FEV1, quality of life, macrolide resistance, adverse effects
At end of study, the median number of exacerbations in the azithromycin group was 0 (interquartile range [IQR], 0-1), compared with 2 (IQR, 1-3) in the placebo group.
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%