Dexamethasone Infusion in Community-acquired Pneumonia

Study Overview
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Brief Summary
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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
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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).

Official Title
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Dexamethasone Infusion in Community-acquired Pneumonia

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>dexamethasone | Drug: dexamethasone<br>* 4 days 5 mg<br>|
| Placebo Comparator: 2<br>Placebo | Drug: dexamethasone<br>* 4 days 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, dexamethasone, community-acquired pneumonia