Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

• Sponsor: Medical Center Alkmaar (Other)
• Overall Status: Completed
• CT.gov ID: NCT00170196
• Collaborator: (none)
• Enrollment: 216
• Location: 1
• Duration (Months): 37
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: prednisone	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Outcome Measures

Primary Outcome Measures

1. Clinical efficacy at the end of treatment []

Secondary Outcome Measures

1. Clinical efficacy at follow up []

2. Inflammation response (serummarkers) []

3. Length of Stay []

4. Time to clinical stability []

5. Mortality []

6. Time to defeverescence []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medisch Centrum Alkmaar	Alkmaar	Noord-Holland	Netherlands	1815 JD

Sponsors and Collaborators

• Medical Center Alkmaar

Investigators

• Principal Investigator: Dominic Snijders, Drs, Pulmo Science
• Study Director: Wim G Boersma, dr, Pulmo Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00170196
• Other Study ID Numbers: M05-018
• First Posted: Sep 15, 2005
• Last Update Posted: Sep 29, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: pneumonia; corticosteroids
• Additional relevant MeSH terms: Pneumonia; Prednisone

Study Results

No Results Posted as of Sep 29, 2008