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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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00952861
Acronym
TAExaCOP
Enrollment
140
Registered
2009-08-06
Start date
2009-10-31
Completion date
2010-12-31
Last updated
2010-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease, Infection, Antibiotics

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

Interventions

DRUGDoxycycline

200 mg QD in 5 days

Placebo QD i 5 days

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
6 minutes walking distanceDay 14

Secondary

MeasureTime frame
Time to next episode of acute exacerbationDays 14, 30, 90 and 180

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026