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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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Doxycycline
Drug: Placebo (matching)
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 6 minutes walking distance [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to next episode of acute exacerbation [ Time Frame: Days 14, 30, 90 and 180 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Doxycycline
Doxycycline 200 mg QD in 5 days
 Drug: Doxycycline
200 mg QD in 5 days
Placebo Comparator: Placebo
Matching placebo QD i 5 days
 Drug: Placebo (matching)
Placebo QD i 5 days

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952861

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Kolding Sygehus
Svendborg Hospital
Fredericia Hospital
Naestved Hospital
Hillerød Hospital
Region Syddanmark
Danmarks Lungeforening
Danish National Research Foundation
Investigators
Study Chair: Court Pedersen, MD Odense University Hospital
  More Information

No publications provided

Responsible Party: Court Pedersen / professor, Department of Infectious Diseases, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00952861     History of Changes
Other Study ID Numbers: OUH-INF-1
Study First Received: July 24, 2009
Last Updated: August 10, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
Chronic obstructive pulmonary disease
Infection
Antibiotics

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Anti-Bacterial Agents
 Doxycycline
Doxycycline hyclate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 17, 2013