Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00170196

Enrollment

216

Registered

2005-09-15

Start date

2005-08-31

Completion date

2008-09-30

Last updated

2008-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

pneumonia, corticosteroids

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

Interventions

DRUGprednisone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Clinical efficacy at the end of treatment	—

Secondary

Measure	Time frame
Inflammation response (serummarkers)	—
Length of Stay	—
Clinical efficacy at follow up	—
Mortality	—
Time to defeverescence	—
Time to clinical stability	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026