title: Necessity of amoxicillin clavulanic acid in addition to prednisolone in mild-to-moderate COPD exacerbations.
abstract: BACKGROUND
  The effectiveness of antibiotics in chronic obstructive pulmonary disease (COPD) exacerbations is still a matter of debate, especially in outpatients with an intermediate probability of bacterial infection.
  
  
  METHODS
  In this study, 35 COPD outpatients diagnosed by their chest physician with moderately severe COPD exacerbation, but without pneumonia, were randomised in a double blind, placebo-controlled study. Patients had one or two of the following characteristics: a positive Gram's stain of the sputum, 2 or more exacerbations in the previous year, a decrease in lung function of >200 mL and >12%. Patients received amoxicillin clavulanic acid (500/125 mg three times daily) or placebo for 7 days, always combined with a course of prednisolone (30 mg/day) for 7 days. Primary outcome was duration of the exacerbation. Additionally, we measured severity of the exacerbation, health-related quality of life, sputum parameters, number of relapses within 28 days and the number of re-exacerbations within 4 months after the study.
  
  
  RESULTS
  There was no difference observed in time to resolution of the exacerbation between the two groups (HR=1.12; (95% CI 0.5 to 2.3; p=0.77)), nor in any other treatment parameter.
  
  
  CONCLUSIONS
  We detected no evidence for the effectiveness of addition of antibiotics to prednisolone for COPD exacerbations of moderate severity and with intermediate probability of bacterial infection in this underpowered study. More placebo-controlled studies are needed to properly define subgroups of COPD outpatients in which antibiotics are of additional value.
  
  
  BACKGROUND
  clinical trial registered with http://www.trialregister.nl/(NTR351).
authors.affiliation: Department of Pulmonary Medicine , Medisch Spectrum Twente , Enschede , The Netherlands.
authors.forename: Marjolein
authors.initials: M
authors.lastname: Brusse-Keizer
authors.affiliation: Department of Pulmonary Medicine , Medisch Spectrum Twente , Enschede , The Netherlands.
authors.forename: Paul
authors.initials: P
authors.lastname: VanderValk
authors.affiliation: Regional Laboratory of Public Health , Enschede , The Netherlands ; Department of Medical Microbiology , University Medical Centre Groningen, and University of Groningen , Groningen , The Netherlands.
authors.forename: Ron
authors.initials: R
authors.lastname: Hendrix
authors.affiliation: Department of Pulmonary Medicine, and Gro ningen Research Institute for Asthma and COPD (GRIAC) , University Of Groningen, University Medical Centre Groningen , Groningen , The Netherlands.
authors.forename: Huib
authors.initials: H
authors.lastname: Kerstjens
authors.affiliation: Department of Pulmonary Medicine , Medisch Spectrum Twente , Enschede , The Netherlands ; Department of Research Methodology, Measurement, and Data Analysis , University of Twente , Enschede , The Netherlands.
authors.forename: Job
authors.initials: J
authors.lastname: van der Palen
keywords: Bacterial Infection; COPD Exacerbations; COPD Pharmacology