Patients with severe infectious AECOPD benefit from 3-month azithromycin course

Takeaway

• In this underpowered trial of patients experiencing acute exacerbation of COPD (AECOPD), treatment failure (TF) rates strongly trended lower during highest-risk period with low-dose azithromycin (Zithromax; Pfizer) vs placebo.

Why this matters

• Whether azithromycin prevents AECOPD-related hospitalizations has not been clear.

Key results

• Azithromycin vs placebo:
  • TF: 49% vs 60%;
    • HR, 0.73 (95% CI, 0.53-1.01; P=.0526).
  • Treatment intensification (TI): 47% vs 60%;
    • HR, 0.70 (95% CI, 0.51-0.97; P=.0272).
  • Step‐up in hospital care (SH): 13% vs 28%;
    • HR, 0.43 (95% CI, 0.25-0.75; P=.0024).
  • Mortality: 2% vs 4%;
    • HR, 0.62 (95% CI, 0.15-2.59; P=.5075).
• Azithromycin group experienced significantly fewer mean cumulative TFs, new exacerbations, total hospital, and ICU days.

Study design

• Multicenter, randomized, double-blind, placebo‐controlled, 9-month BACE trial (n=301).
• Adults hospitalized for infectious AECOPD randomly assigned to azithromycin (500 mg/day for 3 days) vs placebo within 48 hours of admission, then 250 mg every other day for 3 months.
• Outcome: 3-month rate of treatment failure (composite of TI, SH, or all‐cause mortality).
• Funding: Flemish Government Agency for Innovation by Science and Technology (Belgium).

Limitations

• Slow recruitment, funding problems forced enrollment to stop short of anticipated 500 participants.
• May not generalize to noninfectious AECOPD.
• Limited surveillance for antibiotic resistance.