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Dexamethasone Infusion in Community-acquired Pneumonia

Dexamethasone Infusion in Community-acquired Pneumonia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00471640
Acronym
Ovidius
Enrollment
300
Registered
2007-05-10
Start date
2007-11-30
Completion date
2010-09-30
Last updated
2010-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

pneumonia, dexamethasone, community-acquired pneumonia

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).

Interventions

DRUGdexamethasone

4 days 5 mg

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
length of hospital stay30 days

Secondary

MeasureTime frame
side-effects inflammation markers lung function30 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026