Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia
Primary Purpose
Pneumonia
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring pneumonia, corticosteroids
Eligibility Criteria
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
Sites / Locations
- Medisch Centrum Alkmaar
Outcomes
Primary Outcome Measures
Clinical efficacy at the end of treatment
Secondary Outcome Measures
Clinical efficacy at follow up
Inflammation response (serummarkers)
Length of Stay
Time to clinical stability
Mortality
Time to defeverescence
Full Information
NCT ID
NCT00170196
First Posted
September 12, 2005
Last Updated
September 26, 2008
Sponsor
Medical Center Alkmaar
1. Study Identification
Unique Protocol Identification Number
NCT00170196
Brief Title
Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia
Official Title
The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical Center Alkmaar
4. Oversight
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
pneumonia, corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisone
Primary Outcome Measure Information:
Title
Clinical efficacy at the end of treatment
Secondary Outcome Measure Information:
Title
Clinical efficacy at follow up
Title
Inflammation response (serummarkers)
Title
Length of Stay
Title
Time to clinical stability
Title
Mortality
Title
Time to defeverescence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Snijders, Drs
Organizational Affiliation
Pulmo Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wim G Boersma, dr
Organizational Affiliation
Pulmo Science
Official's Role
Study Director
Facility Information:
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
State/Province
Noord-Holland
ZIP/Postal Code
1815 JD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
27317257
Citation
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.
Results Reference
derived
PubMed Identifier
20133929
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia
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