Dexamethasone Infusion in Community-acquired Pneumonia

Not Applicable

Completed

• Conditions: Pneumonia
• Interventions: Drug: dexamethasone

• Registration Number: NCT00471640
• Lead Sponsor: St. Antonius Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2007-05-08
• Study First Submitted QC: 2007-05-08
• Study First Posted: 2007-05-10
• Study Start: 2007-11
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-24
• Last Update Posted: 2010-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	dexamethasone	dexamethasone
2	dexamethasone	Placebo

Primary Outcome Measures

Name	Time	Method
length of hospital stay	30 days

Secondary Outcome Measures

Name	Time	Method
side-effects inflammation markers lung function	30 days

Trial Locations

Locations (2)

St Antonius Hosptial; 🇳🇱 Nieuwegein, Utrecht, Netherlands

Gelderse Vallei Ede; 🇳🇱 Ede, Gelderland, Netherlands