TY - JOUR
T1 - Necessity of amoxicillin clavulanic acid in addition to prednisolone in mild-to-moderate COPD exacerbations
AU - Brusse-Keizer, Marjolein
AU - van der Valk, Paul
AU - Hendrix, Ron
AU - Kerstjens, Huib A.M.
AU - van der Palen, Jacobus Adrianus Maria
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - METIS-308142
KW - IR-93687
U2 - 10.1136/bmjresp-2014-000052
DO - 10.1136/bmjresp-2014-000052
M3 - Article
VL - 1
SP - 1
EP - 7
JO - BMJ open respiratory research
JF - BMJ open respiratory research
SN - 2052-4439
IS - 1
M1 - e000052
ER -