Oral Versus Intravenous Dexamethasone
Phase 3
Completed
- Conditions
- Pneumonia
- Interventions
- Registration Number
- NCT01390012
- Lead Sponsor
- St. Antonius Hospital
- Brief Summary
The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone oral Dexamethasone tablet 6 mg - Dexamethasone intravenous Dexamethasone injection 4 mg -
- Primary Outcome Measures
Name Time Method Area Under the Concentration time curve 0-24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Antonius hospital
🇳🇱Nieuwegein, Utrecht, Netherlands