CRP-guided antibiotic treatment in patients hospitalized with acute exacerbation of COPD patients. The CATCH (CRP guided Antibiotic Treatment in COPD exacerbations admitted at the Hospital) study.

Recruiting

Conditions: bronchitis
lower respiratory tract infection
10004018
10024970

Registration Number: NL-OMON39092

Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

• Age 40 or over. No upper age limit will be employed.
• Written informed consent obtained.
• Change in the patient*s baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD.
• Patients have to be capable of ingesting oral medication.
• Patients have to mentally capable of participating in the study (able to complete questionnaires and perform lung function tests).
• Life expectancy >= 30 days.
• Smoking history > 10 packyears

Exclusion Criteria

Exclusion criteria
• Pregnant or lactating women
• Pretreatment with corticosteroids (cumulative dosis >210 mg) for the present exacerbation.
• Progression or new radiographic abnormalities on the chest X-ray.
• Bronchiectasis (HRCT confirmed).
• Cystic fibrosis
• Tuberculosis
• Immunodeficiency disorders such as AIDS, humoral immune deficiency, ciliary dysfunction etc., and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).
• Recent or unresolved lung malignancy.
• Other disease likely to require antibiotic therapy, such as recurrent sinusitis or urinary tract infection.
• Significant gastrointestinal or other conditions that may affect study drug absorption.
• Class III or IV congestive heart failure or stroke.
• Newly diagnosed pulmonary embolism
• Chonic incresead CRP of any cause (history, lab exam)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>Reduction in antibiotic treatment prescribed in the CRP guided therapy during<br /><br>the period of 30 days after entering the study. Incidence of pulmoanary<br /><br>infiltrates on CT scan in patients with AECOPD.<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The effect of treatment will be estimated by comparing the percentage of<br /><br>treatment failure at day 30.<br /><br>2. Time to next exacerbation reported at 3, 6, and 12 months follow-up.<br /><br>3. Length of hospital stay.<br /><br>4. Symptom scores (VAS-LRTI) on admission, day 14, at day 30.<br /><br>5. Quality of life (Clinical COPD Questionnaire) on admission, 30 days.<br /><br>6. Adverse effects of treatment (days 1-10 and day 30).<br /><br>7. The relation between biomarkers (CRP,PCT) and pulmonary<br /><br>infiltrates observed on CT-scan.</p><br>