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Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT00170196
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 29, 2008
Sponsor:
Information provided by:
Medical Center Alkmaar

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.


Condition or disease Intervention/treatment Phase
Pneumonia Drug: prednisone Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
Study Start Date : August 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Steroids
Drug Information available for: Prednisone
U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical efficacy at the end of treatment

Secondary Outcome Measures :
  1. Clinical efficacy at follow up
  2. Inflammation response (serummarkers)
  3. Length of Stay
  4. Time to clinical stability
  5. Mortality
  6. Time to defeverescence


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008

Keywords provided by Medical Center Alkmaar:
pneumonia
corticosteroids

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents