Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

Medical Center Alkmaar

Status and phase: Completed; Phase 3

Conditions: Pneumonia

Treatments: Drug: prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT00170196

M05-018

Details and patient eligibility

About

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.

Full 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

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind