Oral Versus Intravenous Dexamethasone (OVID)

St. Antonius Hospital

Status and phase: Completed; Phase 3

Conditions: Pneumonia

Treatments: Drug: Dexamethasone injection 4 mg; Drug: Dexamethasone tablet 6 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01390012

OVID

Details and patient eligibility

About

The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Dexamethasone oral

Active Comparator group

Treatment:

Drug: Dexamethasone tablet 6 mg

Dexamethasone intravenous

Active Comparator group

Treatment:

Drug: Dexamethasone injection 4 mg