Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

September 26, 2008 updated by: Medical Center Alkmaar

The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Alkmaar, Noord-Holland, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical efficacy at the end of treatment

Secondary Outcome Measures

Outcome Measure
Mortality
Length of Stay
Clinical efficacy at follow up
Inflammation response (serummarkers)
Time to clinical stability
Time to defeverescence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Center Alkmaar

Investigators

  • Study Director: Wim G Boersma, dr, Pulmo Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2008

Last Update Submitted That Met QC Criteria

September 26, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M05-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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