Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

Phase 3

Completed

• Conditions: Pneumonia

• Registration Number: NCT00170196
• Lead Sponsor: Medical Center Alkmaar

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

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2008-08
• Status Verified: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-09-26
• Last Update Posted: 2008-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical efficacy at the end of treatment

Secondary Outcome Measures

Name	Time	Method
Time to clinical stability
Mortality
Time to defeverescence
Clinical efficacy at follow up
Inflammation response (serummarkers)
Length of Stay

Trial Locations

Locations (1)

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Noord-Holland, Netherlands