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

August 10, 2010 updated by: Odense University Hospital

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 minutes walking distance
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to next episode of acute exacerbation
Time Frame: Days 14, 30, 90 and 180
Days 14, 30, 90 and 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Hillerod Hospital, Denmark
Svendborg Hospital
Naestved Hospital
Kolding Sygehus
Region Syddanmark
Danish National Research Foundation
Danmarks Lungeforening
Fredericia Hospital

Investigators

  • Study Chair: Court Pedersen, MD, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OUH-INF-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe