Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia
The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
1 other identifier
interventional
216
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedSeptember 29, 2008
September 1, 2008
3 years
September 12, 2005
September 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical efficacy at the end of treatment
Secondary Outcomes (6)
Clinical efficacy at follow up
Inflammation response (serummarkers)
Length of Stay
Time to clinical stability
Mortality
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Clinical symptoms of community-acquired pneumonia:
- Fever, cough, sputum, pleural pain, dyspnoea
- Radiological symptoms of pneumoniä
You may not qualify if:
- Any conditions wich requires corticosteroid therapy.
- Pregnancy of lactation
- Malignancy
- Immune-compromised patients (eg chemotherapy or AIDS)
- Pre-treatment with macrolide for \>24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medisch Centrum Alkmaar
Alkmaar, North Holland, 1815 JD, Netherlands
Related Publications (2)
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.
PMID: 27317257DERIVEDSnijders 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.
PMID: 20133929DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominic Snijders, Drs
Pulmo Science
- STUDY DIRECTOR
Wim G Boersma, dr
Pulmo Science
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
August 1, 2005
Primary Completion
August 1, 2008
Study Completion
September 1, 2008
Last Updated
September 29, 2008
Record last verified: 2008-09