Santeon-CAP; Dexamethasone in Community-acquired Pneumonia

• Status: Terminated
• Trial end date: 2018-09-13
• Target enrollment: 0
• Participant gender: All

Summary

The present study is designed to investigate the beneficial effects of adjunctive dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally aiming at assessing what patients benefit from dexamethasone treatment mostly. A large multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with placebo in 600 patients and with predefined subgroup analyses planned.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Antonius Hospital
• Collaborators: Canisius-Wilhelmina Hospital; Catharina Ziekenhuis Eindhoven; Maasstad Hospital; Onze Lieve Vrouw Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 18 years or older

• 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 leucopenia (<4000 cells/mm3)

• C-reactive protein > 15 mg/l (three fold higher than the upper limit of normal)

Exclusion Criteria:

• Immunocompromised patients:

• Patients with a known congenital or acquired 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 (e.g. cyclosporin, cyclophosphamide, azathioprine).

• Patients with chronic obstructive pulmonary disease who are on systemic corticosteroids.

• Patients who require intensive care unit treatment.

• Patients with tropical worm infection.

• Patients with dexamethasone intolerance.

• Pregnant and breastfeeding women.