The effects of the use of antibiotics during acute exacerbations in chronic obstructive pulmonary disease (COPD) on the severity and duration of exacerbations: the ABC-trial

Medisch Spectrum Twente (Netherlands)0 sites35 target enrollmentDecember 19, 2005

Overview

Registry

who.int

Start Date

December 19, 2005

End Date

January 1, 2007

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Medisch Spectrum Twente (Netherlands)

•1\. Patients of the outpatient clinic of the Medical Spectrum Twente
•2\. Aged between 40 and 75 years
•3\. A clinical diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
•4\. A signed and dated written informed consent from the subject prior to study participation
•5\. Patients with COPD presenting one or two of the following characteristics:
•5\.1\. A positive Gram?s stain of the sputum
•5\.2\. A clinically relevant decrease of lung function, defined as a decrease in forced expiratory volume in one second (FEV1\) of 200 ml or more and 12% or more from baseline value
•5\.3\. Two or more exacerbations in the previous year
•6\. Present with signs and symptoms of an exacerbation at the outpatient clinic
•7\. Current smoker or ex\-smoker

•1\. Serious other disease with a low survival rate
•2\. Clinical symptoms (e.g. temperature greater than 38\.5°C), indicating pneumonia and a thorax X\-ray positive for pneumonia
•3\. Another disease, which influences bronchial symptoms and/or lung function (e.g. cardiac insufficiency, sarcoidosis, pulmonary embolism, rib fracture, pneumonia and bronchial carcinoma)
•4\. Severe psychiatric illness
•5\. Uncontrolled diabetes mellitus
•6\. Need for regular oxygen therapy
•7\. Maintenance therapy with antibiotics
•8\. Subject with a known hypersensitivity to amoxicillin/clavulanic acid (Augmentin®)
•9\. Use of antibiotic 4 weeks before study entry
•10\. Use of prednisolone (except for a maintenance ration) 4 weeks before study entry