title: Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease.
abstract: BACKGROUND
  Antimicrobial therapy remains a controversial issue in nonsevere exacerbations of chronic obstructive pulmonary disease (COPD).
  
  
  OBJECTIVE
  To evaluate the efficacy of antibiotic therapy in moderate exacerbations of mild-to-moderate COPD.
  
  
  METHODS
  This study involved a multicenter, parallel, double-blind, placebo-controlled, randomized clinical trial. Patients aged 40 years or older, smokers, or ex-smokers of 10 pack-years or more with spirometrically confirmed mild-to-moderate COPD (FEV(1) > 50% predicted and FEV(1)/FVC ratio < 0.7) and diagnosed with an exacerbation were enrolled in the study. The patients were randomized to receive amoxicillin/clavulanate 500/125 mg three times a day or placebo three times a day for 8 days.
  
  
  RESULTS
  The primary outcome measure was clinical cure at end of therapy visit (EOT) at Days 9 to 11. A total of 310 subjects fulfilled all the criteria for efficacy analysis. A total of 117 patients with amoxicillin/clavulanate (74.1%) and 91 with placebo (59.9%) were considered cured at EOT (difference, 14.2%; 95% confidence interval, 3.7-24.3). The median time to the next exacerbation was significantly longer in patients receiving antibiotic compared with placebo (233 d [interquartile range, 110-365] compared with 160 d [interquartile range, 66-365]; P < 0.05). The best C-reactive protein serum cut-off for predicting clinical failure with placebo was 40 mg/L, with an area under the curve of 0.732 (95% confidence interval, 0.614-0.851).
  
  
  CONCLUSIONS
  Treatment of ambulatory exacerbations of mild-to-moderate COPD with amoxicillin/clavulanate is more effective and significantly prolongs the time to the next exacerbation compared with placebo.
authors.affiliation: 1University Rovira i Virgili, Primary Care Center Jaume I,c. Felip Pedrell, 45-47, Tarragona, Spain. carles.llor@urv.cat
authors.forename: Carl
authors.initials: C
authors.lastname: Llor
authors.forename: Ana
authors.initials: A
authors.lastname: Moragas
authors.forename: Silvia
authors.initials: S
authors.lastname: Hernández
authors.forename: Carolina
authors.initials: C
authors.lastname: Bayona
authors.forename: Marc
authors.initials: M
authors.lastname: Miravitlles
mesh_terms: D000368:Aged; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D015999:Multivariate Analysis; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents; D015415:Biomarkers; D019980:Amoxicillin-Potassium Clavulanate Combination; D002097:C-Reactive Protein