COPD Clinical Trial
— CATCHOfficial title:
CRP-guided Antibiotic Treatment in Patients Hospitalized With Acute Exacerbations of COPD Patients. A Randomized Controlled Intervention Trial.
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 exacerbations are often treated with a combination of corticosteroids, bronchodilators and antibiotics, but the benefit of antibiotic therapy remains controversial. Several trials studying antibiotic treatment in AECOPD showed conflicting data, with several large studies failing to demonstrate superiority of antibiotic therapy over placebo. Other trials indicated that antibiotic therapy is effective in patients who have at least two of the following symptoms: increased dyspnoea, increased sputum volume and increased sputum purulence. Ever since sputum purulence has been used as a predictive marker in AECOPD, a strategy that has been integrated in the GOLD guideline for treatment of AECOPD. However, the color of sputum reported by patients is not always reliable and inspection of sputum is not always possible. Several serum biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT) are now available. In a recent trial of doxycycline in addition to systemic corticosteroids for patients hospitalized with AECOPD we found that CRP might be valuable as a marker predictive of response to antibiotic treatment in AECOPD.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | July 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | W.G.Boersma | Alkmaar | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Medical Center Alkmaar |
Netherlands,
Daniels JM, Snijders D, de Graaff CS, Vlaspolder F, Jansen HM, Boersma WG. Antibiotics in addition to systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Jan 15;181(2):150-7. doi: 10.1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients treated with antibiotics during hospital stay | Sputum purulence has been used as a predictive marker in AECOPD.However, the color of sputum reported by patients is not always reliable and inspection of sputum is not always possible. Serum biomarker such as C-reactive protein (CRP) represents systemic inflammation.In the present study, we will compare CRP guided antibiotic treatment versus treatment according to GOLD strategy. Our hyposthesis is that CRP-guided therapy results in lower number of antibiotic prescriptions | 10 days | No |
Secondary | Time to treatment failure within 30-days | Treatment failure within 30 days after hospital admission will be compared | 30 days | No |
Secondary | Length of stay | Length of hospital stay for the exacerbation | 30 days | No |
Secondary | Time to next exacerbation | Time to the next exacerbation with a follow-up period of one year | 1 year | No |
Secondary | Symptom scores (VAS-LRTI, George's Respiratory Questionnaire) | Symptom score (VAS-LRTI) and Quality of life (George's Respiratory Questionnaire) will be measured at onset and recovery. | 30 days | No |
Secondary | Adverse events | Adverse events of antibiotic treatment are recorded during follow-up | 30 days | Yes |
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