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Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results.
Eur Respir J. 2012 Jul; 40(1):17-27.ER

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.

Authors+Show Affiliations

Host Defence Unit, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK. r.wilson@rbht.nhs.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22135277

Citation

Wilson, Robert, et al. "Moxifloxacin Versus Amoxicillin/clavulanic Acid in Outpatient Acute Exacerbations of COPD: MAESTRAL Results." The European Respiratory Journal, vol. 40, no. 1, 2012, pp. 17-27.
Wilson R, Anzueto A, Miravitlles M, et al. Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results. Eur Respir J. 2012;40(1):17-27.
Wilson, R., Anzueto, A., Miravitlles, M., Arvis, P., Alder, J., Haverstock, D., Trajanovic, M., & Sethi, S. (2012). Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results. The European Respiratory Journal, 40(1), 17-27. https://doi.org/10.1183/09031936.00090311
Wilson R, et al. Moxifloxacin Versus Amoxicillin/clavulanic Acid in Outpatient Acute Exacerbations of COPD: MAESTRAL Results. Eur Respir J. 2012;40(1):17-27. PubMed PMID: 22135277.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results. AU - Wilson,Robert, AU - Anzueto,Antonio, AU - Miravitlles,Marc, AU - Arvis,Pierre, AU - Alder,Jeff, AU - Haverstock,Daniel, AU - Trajanovic,Mila, AU - Sethi,Sanjay, Y1 - 2011/12/01/ PY - 2011/12/3/entrez PY - 2011/12/3/pubmed PY - 2013/5/29/medline SP - 17 EP - 27 JF - The European respiratory journal JO - Eur Respir J VL - 40 IS - 1 N2 - 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. SN - 1399-3003 UR - https://www.unboundmedicine.com/medline/citation/22135277/Moxifloxacin_versus_amoxicillin/clavulanic_acid_in_outpatient_acute_exacerbations_of_COPD:_MAESTRAL_results_ L2 - http://erj.ersjournals.com:4040/lookup/pmidlookup?view=long&amp;pmid=22135277 DB - PRIME DP - Unbound Medicine ER -