Status:
UNKNOWN
CRP-guided Antibiotic Treatment in COPD Exacerbations Admitted to the Hospital
Lead Sponsor:
Medical Center Alkmaar
Conditions:
COPD
Exacerbation
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Rationale: Acute exacerbations are key events in chronic obstructive pulmonary disease (COPD), resulting in poorer quality of life. Causes include irritants, viruses and bacterial pathogens. These exa...
Detailed Description
Objective: CRP-guided antibiotic therapy will be compared with standard antibiotic therapy in AECOPD. Our aim is that CRP guided therapy will lead to 20% reduction in antibiotic consumption. Study de...
Eligibility Criteria
Inclusion
- Age 40 or over. No upper age limit will be employed.
- Written informed consent obtained.
- AECOPD according to the GOLD guideline. An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD.
- Criteria for hospital admission according to the GOLD: marked increase in symptoms (i.e. resting dyspnoea), severe underlying COPD, onset of new physical signs (cyanosis, edema), failure to respond to initial medical management, significant co morbidities, frequent exacerbations, newly occurring arrhythmias, diagnostic uncertainty.
- Former of current smoker with a minimum smoking history of 10 pack years.
- Patients have to be capable of ingesting oral medication.
- Patients have to be mentally capable of participating in the study (able to complete questionnaires and perform lung function tests).
- Life expectancy ≥ 30 days.
Exclusion
- Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
- Pretreatment with corticosteroids (cumulative dose \>210 mg) for the present exacerbation.
- Progression or new radiographic abnormalities on the chest X-ray or CT scan compatible with pneumonia.
- bronchiectasis (HRCT confirmed).
- Cystic fibrosis.
- Tuberculosis.
- Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs (\>30 mg prednisolone/day maintenance dose or equivalent for more than 4 weeks).
- Recent or unresolved lung malignancy.
- Other disease likely to require antibiotic therapy, such as recurrent sinusitis or urinary tract infection.
- Significant gastrointestinal or other conditions that may affect study drug absorption.
- Class III or IV congestive heart failure or stroke.
- Newly diagnosed pulmonary embolism
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01232140
Start Date
July 1 2011
End Date
July 1 2013
Last Update
March 22 2012
Active Locations (1)
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1
W.G.Boersma
Alkmaar, North Holland, Netherlands, 1829JC