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NCT00170196 Clinical Trial

Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

Pneumonia Clinical Trial

Official title:
The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00170196
Other study ID # M05-018
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated September 26, 2008
Start date August 2005
Est. completion date September 2008

Study information
Verified date September 2008
Source Medical Center Alkmaar
Contact n/a
Is FDA regulated No
Health authority Netherlands: Dutch Health Care Inspectorate
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 216
Est. completion date September 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• prednisone

Locations
Country Name City State
Netherlands Medisch Centrum Alkmaar Alkmaar Noord-Holland

Sponsors (1)
Lead Sponsor Collaborator
Medical Center Alkmaar

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical efficacy at the end of treatment
Secondary Clinical efficacy at follow up
Secondary Inflammation response (serummarkers)
Secondary Length of Stay
Secondary Time to clinical stability
Secondary Mortality
Secondary Time to defeverescence
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