Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

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

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
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170196

Medisch Centrum Alkmaar
Alkmaar, Noord-Holland, Netherlands, 1815 JD
Sponsors and Collaborators
Medical Center Alkmaar
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:

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014