Dexamethasone Infusion in Community-acquired Pneumonia (Ovidius)

September 24, 2010 updated by: St. Antonius Hospital
The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Community-acquired pneumonia (CAP) is common and approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring ICU admission.1 Especially elderly patients may have a severe illness with a high morbidity and mortality rate. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a useful mechanism in the elimination of invading pathogens. However, this natural reaction can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung.

Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Hypothetically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

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
    • Gelderland
      • Ede, Gelderland, Netherlands
        • Gelderse Vallei Ede
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3430 EM
        • St Antonius Hosptial

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:

Patients aged 18 to 100 years with a community-acquired pneumonia.

Criteria to determine a community-acquired pneumonia:

  • Chest radiograph showing new opacities

  • In combination with two of the following findings:

    • Cough
    • Production of sputum
    • Temp >38,0 °C or <36,0 °C
    • Audible abnormalities by chest examination compatible with pneumonia
    • Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leukopenia (<4000 cells/mm3)
    • CRP > 15 mg/dl (three times upper limit of normal)

Exclusion Criteria:

  • o The following groups are excluded:

    • Immunocompromised patients:

      • Patients with a known congenital or achieved immunodeficiency.
      • Patients who received chemotherapy less than 6 weeks ago.
      • Patients who received corticosteroids in the last 6 weeks.
      • Patients who received immunosuppressive medication in the last 6 weeks. (like cyclosporine, cyclofosfamide, azathioprine)
      • Patients with COPD who are on systemic corticosteroids for COPD.
      • Patients who require ICU treatment.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: dexamethasone
4 days 5 mg
Active Comparator: 1
dexamethasone
Drug: dexamethasone
4 days 5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of hospital stay
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
side-effects inflammation markers lung function
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

St. Antonius Hospital

Investigators

  • Study Director: D Biesma, dr., St. Antonius Hospital

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

November 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 8, 2007

First Submitted That Met QC Criteria

May 8, 2007

First Posted (Estimate)

May 10, 2007

Study Record Updates

Last Update Posted (Estimate)

September 27, 2010

Last Update Submitted That Met QC Criteria

September 24, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • versie 1

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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