Moxifloxacinversusamoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results

Abstract

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.

Bronchiectasis as a Comorbidity of Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis

“…The presence of bacteria in the lower airways in COPD impairs host defense mechanisms, which results in epithelial cell integrity disruption and inflammation, further airway structural damage, which could be the mechanism for longer and more severe COPD exacerbations [19]. Incomplete resolution of bacterial infection or bacterial colonization was considered to be a risk for relapse, and therefore appropriate and effective antibiotic therapy for bacterial infection in exacerbation of COPD with bronchiectasis may be important in preventing exacerbations and relapses or delaying subsequent exacerbations [36][37][38]. But to date, appropriate modalities for bacterial eradication, particularly for those with chronic bacterial colonization, haven't been established.…”

Predictors for antibiotic prescribing in patients with exacerbations of COPD in general practice

“…Microbiological analysis was not assessed in our study because it is not readily available in primary care centres. Positive cultures are only obtained in 20-60% of sputum samples of patients included in clinical trials with types I and II exacerbations [Daniels et al 2010;Wilson et al 2012]. The GOLD guidelines recognize that sputum cultures take too long, at least 2 days, and frequently do not give reliable results for technical reasons [Global Initiative for Chronic Obstructive Lung Disease, 2011].…”

Lewofloksacyna i moksyfloksacyna w leczeniu zakażeń bakteryjnych

“…Porównawcze badanie moksyfloksacyny z dotychczas rekomendowaną antybiotykoterapią (amoksycylina z kwasem klawulanowym) -MAESTRAL (ang. moxifloxacin in acute exacerbations of chronic bronchitis trial) -wykazało porównywalną dobrą tolerancję obu terapii, ale większą skuteczność moksyfloksacyny [59].…”