The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pneumonia
- Sponsor
- Medical Center Alkmaar
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Clinical efficacy at the end of treatment
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in patient admitted with Community-acquired pneumonia.
The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in improving clinical outcome in patients hospitalized with CAP.
Detailed Description
Community-acquired pneumonia (CAP) is a acute illness with a considerable morbidity and mortality, especially patients with severe CAP. In the past decennia, in spite of many investigations, little reduction is seen in morbidity an mortality. Corticosteroids have a immune-modulation effect, which is not completely elucidated. Most likely the immune modulation effect is due to down-regulation of pro-inflammatory cytokines. The use of corticosteroids next to antibiotics in CAP could lead to shorter time to clinical stability, length of stay and costs. Comparison: Hospitalized patients with CAP treated with antibiotics and prednisolone versus hospitalized patients with cap treated with antibiotics and placebo
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical symptoms of community-acquired pneumonia:
- •Fever, cough, sputum, pleural pain, dyspnoea
- •Radiological symptoms of pneumoniä
Exclusion Criteria
- •Any conditions wich requires corticosteroid therapy.
- •Pregnancy of lactation
- •Malignancy
- •Immune-compromised patients (eg chemotherapy or AIDS)
- •Pre-treatment with macrolide for \>24 hours
Outcomes
Primary Outcomes
Clinical efficacy at the end of treatment
Secondary Outcomes
- Clinical efficacy at follow up
- Inflammation response (serummarkers)
- Length of Stay
- Time to clinical stability
- Mortality
- Time to defeverescence