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Antibiotics in Chronic Obstructive Pulmonary Disease (COPD) (TAExaCOP)

This study has been withdrawn prior to enrollment.
(Stopped due to poor recruitment)
Sponsor:
Collaborators:
Kolding Sygehus
Svendborg Hospital
Fredericia Hospital
Naestved Hospital
Hillerød Hospital
Region Syddanmark
Danmarks Lungeforening
Danish National Research Foundation
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00952861
First received: July 24, 2009
Last updated: August 10, 2010
Last verified: June 2010
History of Changes

July 24, 2009
August 10, 2010
October 2009
October 2010   (final data collection date for primary outcome measure)
6 minutes walking distance [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00952861 on ClinicalTrials.gov Archive Site
Time to next episode of acute exacerbation [ Time Frame: Days 14, 30, 90 and 180 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)
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

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Doxycycline
    200 mg QD in 5 days
  • Drug: Placebo (matching)
    Placebo QD i 5 days
  • Active Comparator: Doxycycline
    Doxycycline 200 mg QD in 5 days
    Intervention: Drug: Doxycycline
  • Placebo Comparator: Placebo
    Matching placebo QD i 5 days
    Intervention: Drug: Placebo (matching)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
140
December 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00952861
OUH-INF-1
No
Court Pedersen / professor, Department of Infectious Diseases, Odense University Hospital
Odense University Hospital
  • Kolding Sygehus
  • Svendborg Hospital
  • Fredericia Hospital
  • Naestved Hospital
  • Hillerød Hospital
  • Region Syddanmark
  • Danmarks Lungeforening
  • Danish National Research Foundation
Study Chair: Court Pedersen, MD Odense University Hospital
Odense University Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP