BAT
Trial question
What is the role of azithromycin maintenance treatment on infectious exacerbations in adult patients with non-cystic fibrosis bronchiectasis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
64.0% female
36.0% male
N = 83
83 patients (53 female, 30 male).
Inclusion criteria: adult patients with non-cystic fibrosis bronchiectasis and ≥ 3 lower respiratory tract infections in the preceding year.
Key exclusion criteria: prolonged (> 4 weeks) macrolide therapy during the previous 3 months, oral or intravenous courses of corticosteroids within 30 days of screening, any antimicrobial treatment for an LRTI in the last 2 weeks, known allergy or intolerance to macrolides, or patients with liver disease.
Interventions
N=43 azithromycin (250 mg daily for 12 months).
N=40 placebo (matching placebo daily for 12 months).
Primary outcome
Median number of infectious exacerbations at 12 months
0
2
-0.5 (IQR 0...
-1.0 (IQR 0...
-1.5 (IQR 0...
-2.0 (IQR 0...
Azithromycin
Placebo
Significant
increase ▲
Significant increase in median number of infectious exacerbations at 12 months (0 (IQR 0-1) vs. 2 (IQR 0-1)).
Secondary outcomes
Significant decrease in exacerbation, at least 1 (46% vs. 80%; HR 0.29, 95% CI 0.16 to 0.51).
Safety outcomes
Significant differences in gastrointestinal adverse effects (40% vs 5%), including abdominal pain (19% vs. 3%) and diarrhea (21% vs. 3%) and macrolide resistance (88% vs. 26%).
Conclusion
In adult patients with non-cystic fibrosis bronchiectasis and ≥ 3 lower respiratory tract infections in the preceding year, azithromycin was superior to placebo with respect to median number of infectious exacerbations at 12 months.
Reference
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.
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