Antibiotic treatment in patients hospitalized with an acute exacerbation in chronic obstructive pulmonary disease. Effect of one day of antibiotic treatment compared t0 6 days of antibiotic treatment in patients who are clinically stable 24 hours after hospitalization. A prospective, randomized, double-blind trial - TaexaCOP

Conditions: Acute exacerbation of chronic ostructive pulmonary disease in hospitalized patients. All patients receive standard of care, and 1 day of intravenous antibiotics. In addition patients are randomized to treatment with Vibradox 200 mg QD in 5 days or matching placebo. The primary outcome variable is 6 minutes walking distance at day 14 after hospitalization.
MedDRA version: 9.1Level: LLTClassification code 10056971Term: Infective exacerbation of chronic obstructive airways disease

Registration Number: EUCTR2007-007275-16-DK

Lead Sponsor: Department of Infetious Diseases, Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Age >= 50 years
2) History of smoking
3) History of COPD
4) Symptoms of acute exacerbation in COPD
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Pneumonia
2) Antibiotics given for >= 36 hours before admission
3) Patients in whom doxycyklin is contraindicated
4) Patients with cancer, epilepsia or severe heart, kidney og liver dysfunction
5) Patients in terminal phase of COPD
6) Patients with tuberculosis or aspergillosis
7) Patients in need for intensive care or with progressive disease within the first 24 hours of hospitalization

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether antibiotics (doxycyklinn) improves recovery as measured by 6 minutes walking distance ad days 7 and 14 after an episode of acute exacerbation in chronic pulmonary disease.;Secondary Objective: To investigate whether antibiotics (doxycyklin) improves:<br>1) Duration of hospitalization<br>2) Duration of pulmonary symptoms<br>3) Clinical and microbiological cure<br>4) Pulmonary function<br>5) Mortality<br>6) Time to new epsiode<br>7) Quality of Life<br>8) Side effects;Primary end point(s): 6 minute walking distance at day 14

Secondary Outcome Measures