Dexamethasone infusion in community-acquired pneumonia - Ovidius studie

• Conditions: pneumonia; MedDRA version: 9.1Level: LLTClassification code 10035664Term: Pneumonia

• Registration Number: EUCTR2007-002612-25-NL
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-
oPatients aged 18 to 100 years with a community-acquired pneumonia, which requires admission.
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/l (three times upper limit of normal)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-
oThe 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.
§Pregnant women
§Patients with dexamethasone intolerance
§Patients with a tropical worm infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified