Study Stopped
Stopped due to poor recruitment
Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)
TAExaCOP
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
1 other identifier
interventional
140
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 11, 2010
June 1, 2010
1 year
July 24, 2009
August 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 minutes walking distance
Day 14
Secondary Outcomes (1)
Time to next episode of acute exacerbation
Days 14, 30, 90 and 180
Study Arms (2)
Doxycycline
ACTIVE COMPARATORDoxycycline 200 mg QD in 5 days
Placebo
PLACEBO COMPARATORMatching placebo QD i 5 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Kolding Sygehuscollaborator
- Svendborg Hospitalcollaborator
- Fredericia Hospitalcollaborator
- Naestved Hospitalcollaborator
- Hillerod Hospital, Denmarkcollaborator
- Region Syddanmarkcollaborator
- Danmarks Lungeforeningcollaborator
- Danish National Research Foundationcollaborator
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Court Pedersen, MD
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 24, 2009
First Posted
August 6, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
August 11, 2010
Record last verified: 2010-06