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Trial record 1 of 1 for:    NCT00471640
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Dexamethasone Infusion in Community-acquired Pneumonia (Ovidius)

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ClinicalTrials.gov Identifier: NCT00471640
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : September 27, 2010
Sponsor:
Information provided by:
St. Antonius Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: dexamethasone Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone Infusion in Community-acquired Pneumonia
Study Start Date : November 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
dexamethasone
 Drug: dexamethasone
4 days 5 mg
Placebo Comparator: 2
Placebo
 Drug: dexamethasone
4 days 5 mg


Outcome Measures
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Primary Outcome Measures :
  1. length of hospital stay [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. side-effects inflammation markers lung function [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471640


Locations
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Netherlands
Gelderse Vallei Ede
Ede, Gelderland, Netherlands
St Antonius Hosptial
Nieuwegein, Utrecht, Netherlands, 3430 EM
Sponsors and Collaborators
St. Antonius Hospital
Investigators
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Study Director: D Biesma, dr. St. Antonius Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT00471640    
Other Study ID Numbers: versie 1
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010
Keywords provided by St. Antonius Hospital:
pneumonia
dexamethasone
community-acquired pneumonia
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents