Bacterial infections causing acute exacerbations of
chronic obstructive pulmonary disease (AECOPD) frequently require antibacterial treatment. More evidence is needed to guide
antibiotic choice. The
Moxifloxacin in Acute Exacerbations of
Chronic Bronchitis TriaL (MAESTRAL) was a multiregional, randomised, double-blind non-inferiority outpatient study. Patients were aged ≥ 60 yrs, with an Anthonisen type I exacerbation, a forced expiratory volume in 1 s < 60% predicted and two or more exacerbations in the last year. Following stratification by
steroid use patients received
moxifloxacin 400 mg p.o. q.d. (5 days) or
amoxicillin/clavulanic acid 875/125 mg p.o. b.i.d. (7 days). The primary end-point was clinical failure 8 weeks post-
therapy in the per protocol population.
Moxifloxacin was noninferior to
amoxicillin/clavulanic acid at the primary end-point (111 (20.6%) out of 538, versus 114 (22.0%) out of 518, respectively; 95% CI -5.89-3.83%). In patients with confirmed bacterial AECOPD,
moxifloxacin led to significantly lower clinical failure rates than
amoxicillin/clavulanic acid (in the intent-to-treat with pathogens, 62 (19.0%) out of 327 versus 85 (25.4%) out of 335, respectively; p=0.016). Confirmed bacterial eradication at end of
therapy was associated with higher clinical cure rates at 8 weeks post-
therapy overall (p=0.0014) and for
moxifloxacin (p=0.003). Patients treated with oral
corticosteroids had more severe disease and higher failure rates. The MAESTRAL study showed that
moxifloxacin was as effective as
amoxicillin/clavulanic acid in the treatment of outpatients with AECOPD. Both
therapies were well tolerated.