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Completed

NCT Number: NCT00471640

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gelderse Vallei Ede, Ede, Gelderland, Netherlands

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

4 days 5 mg

Primary outcomes

  1. length of hospital stay

    Time frame: 30 days

Secondary outcomes

  1. side-effects inflammation markers lung function

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Acronym: Ovidius

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 10, 2007
Registry last updated
Sep 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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