- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170196
Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia
The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Noord-Holland
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Alkmaar, Noord-Holland, Netherlands, 1815 JD
- Medisch Centrum Alkmaar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical efficacy at the end of treatment
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Secondary Outcome Measures
Outcome Measure |
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Mortality
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Length of Stay
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Clinical efficacy at follow up
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Inflammation response (serummarkers)
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Time to clinical stability
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Time to defeverescence
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wim G Boersma, dr, Pulmo Science
Publications and helpful links
General Publications
- Raeven VM, Spoorenberg SM, Boersma WG, van de Garde EM, Cannegieter SC, Voorn GP, Bos WJ, van Steenbergen JE; Alkmaar study group; Ovidius study group. Atypical aetiology in patients hospitalised with community-acquired pneumonia is associated with age, gender and season; a data-analysis on four Dutch cohorts. BMC Infect Dis. 2016 Jun 17;16:299. doi: 10.1186/s12879-016-1641-9.
- Snijders D, Daniels JM, de Graaff CS, van der Werf TS, Boersma WG. Efficacy of corticosteroids in community-acquired pneumonia: a randomized double-blinded clinical trial. Am J Respir Crit Care Med. 2010 May 1;181(9):975-82. doi: 10.1164/rccm.200905-0808OC. Epub 2010 Feb 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M05-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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