To compare the pharmacokinetics and pharmacodynamics of dexamethasone per os and intravenously

Conditions: Patients with confirmed community-acquired pneumonia admitted to the hospital
MedDRA version: 13.1Level: PTClassification code 10035664Term: PneumoniaSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-002346-12-NL

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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, ausculatory 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Patients needing corticosteroid treatment above study medication
- Failure to obtain written consent to participate
- Patients using fenytoine, barbiturates, rifampicine, erythromycin, clarithromycine, aprepitant, colchicine, everolimus, itraconazol, ketoconazole, pazopamib, tipranavir, vinorelbin
- Moribund patients (defined as expected to die within 24 hours)
- Patients with proven or suspected allergy to dexamethasone

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the pharmacokinetics of intravenous versus oral dexamethasone in patients admitted for pneumonia;Secondary Objective: To compare the pharmacodynamics of intravenous versus oral dexamethasone in patients admitted for pneumonia;Primary end point(s): Extent of exposure reflected by the area under concentration time curve<br>;Timepoint(s) of evaluation of this end point: 96 hours after the first administration

Secondary Outcome Measures