Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

— TAExaCOP  

Official title:

Antibiotic Treatment of Patients Admitted to Hospital With Acute Exacerbation of COPD. Effect of 1 Day of Antibiotic Therapy Compared to 6 Days of Therapy in Patients Who Are Stable After 24 Hours

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00952861
• Other study ID #: OUH-INF-1
• Status: Withdrawn
• Phase: Phase 4
• First received: July 24, 2009
• Last updated: August 10, 2010
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2010
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 140
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age above 50 years

• History of smoking

• History of COPD

• Antibiotics for 24 hours

• At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence

• Informed consent

Exclusion Criteria:

• Pneumonia

• Antibiotics for more than 36 hours

• Antibiotics for other infection

• Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days

• Malignancy

• Other pulmonary disease

• Immune deficiency

• Not able to tolerate doxycycline

• Severe heart, liver or kidney disease

• Epilepsia

• Not stable 24 hours after hospital admission

• Need for assisted ventilation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Doxycycline
200 mg QD in 5 days
• Placebo (matching)
Placebo QD i 5 days

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (9)

Lead Sponsor	Collaborator
Odense University Hospital	Danish National Research Foundation, Danmarks Lungeforening, Fredericia Hospital, Hillerod Hospital, Denmark, Kolding Sygehus, Naestved Hospital, Region Syddanmark, Svendborg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minutes walking distance		Day 14	No
Secondary	Time to next episode of acute exacerbation		Days 14, 30, 90 and 180	No