Dexamethasone Infusion in Community-acquired Pneumonia

Pneumonia Clinical Trial

— Ovidius  

Official title:

Dexamethasone Infusion in Community-acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471640
• Other study ID #: versie 1
• Status: Completed
• Phase: N/A
• First received: May 8, 2007
• Last updated: September 24, 2010
• Start date: November 2007
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• dexamethasone
4 days 5 mg

Locations

Country	Name	City	State
Netherlands	Gelderse Vallei Ede	Ede	Gelderland
Netherlands	St Antonius Hosptial	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hospital stay		30 days	Yes
Secondary	side-effects inflammation markers lung function		30 days	Yes