Dexamethasone Infusion in Community-acquired Pneumonia (Ovidius)

This study has been completed.
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00471640
First received: May 8, 2007
Last updated: September 24, 2010
Last verified: September 2010

May 8, 2007
September 24, 2010
November 2007
September 2010   (final data collection date for primary outcome measure)
length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
lenght of hospital stay [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00471640 on ClinicalTrials.gov Archive Site
side-effects inflammation markers lung function [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
side-effects inflammation markers lung function [ Time Frame: 30 days ]
Not Provided
Not Provided
 
Dexamethasone Infusion in Community-acquired Pneumonia
Dexamethasone Infusion in Community-acquired Pneumonia

The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pneumonia
Drug: dexamethasone
4 days 5 mg
  • Active Comparator: 1
    dexamethasone
    Intervention: Drug: dexamethasone
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: dexamethasone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00471640
versie 1
Yes
St. Antonius Hospital
St. Antonius Hospital
Not Provided
Study Director: D Biesma, dr. St. Antonius Hospital
St. Antonius Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP