Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00170196
First received: September 12, 2005
Last updated: September 26, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Pneumonia
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids

Resource links provided by NLM:


Further study details as provided by Medical Center Alkmaar:

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

Enrollment: 216
Study Start Date: August 2005
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170196

Locations
Netherlands
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
  More Information

No publications provided by Medical Center Alkmaar

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00170196     History of Changes
Other Study ID Numbers: M05-018
Study First Received: September 12, 2005
Last Updated: September 26, 2008
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Medical Center Alkmaar:
pneumonia
corticosteroids

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 22, 2014