Dexamethasone Infusion in Community-acquired Pneumonia (Ovidius)
The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Dexamethasone Infusion in Community-acquired Pneumonia|
- length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- side-effects inflammation markers lung function [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
4 days 5 mg
Placebo Comparator: 2
4 days 5 mg
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).
|Gelderse Vallei Ede|
|Ede, Gelderland, Netherlands|
|St Antonius Hosptial|
|Nieuwegein, Utrecht, Netherlands, 3430 EM|
|Study Director:||D Biesma, dr.||St. Antonius Hospital|