Pneumonia
Conditions
Brief summary
The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.
Interventions
DRUGDexamethasone tablet 6 mg
Dexamethasone tablet 6 mg
DRUGDexamethasone injection 4 mg
Dexamethasone injection 4 mg
Sponsors
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years and older * Presenting to the emergency room with suspected pneumonia (to be confirmed within 24 hours from admission) Pneumonia is defined as a new or progressive infiltrate on a chest X-ray plus at least two of the following criteria: cough, sputum production, temperature \>38°C or \<35°C, auscultatory findings consistent with pneumonia, leucocytosis or leucopenia (\>10 g/l, \<4 g/l or \>10% rods in leucocyte differentiation), C-reactive protein \>3 times the upper normal limit Corticosteroid naive at time of presentation
Exclusion criteria
* Patients needing corticosteroid treatment above study medication * Failure to obtain written consent to participate * Patients using medication drugs that interact with dexamethasone (i.e. phenytoin, barbiturates, rifampicin, erythromycin, clarithromycin, aprepitant, colchicine, everolimus, itraconazole, ketoconazole, pazopanib, tipranavir, and vinorelbine) * Moribund patients (defined as expected to die within 24 hours) * Patients with proven or suspected allergy to dexamethasone * Patients not capable of taking tablets orally
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration time curve | 0-24 hours |
Countries
Netherlands
Outcome results
None listed