Pharmacokinetics of oseltamivir in patients with infection due to influenza A H1N1 2009 admitted in intensive care unit.
Phase 1
- Conditions
- severe infection due to influenza A H1N1MedDRA version: 12.1Level: LLTClassification code 10022002Term: Influenza A virus infection
- Registration Number
- EUCTR2009-017350-13-BE
- Lead Sponsor
- Erasme Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
All successive patients admitted into ICU with suspected or confirmed flu, with or without signs of severe sepsis or septic shock.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Adult patients or adolescents with body weight less than 45kg
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): ;Main Objective: The objective is to determine the pharmacokinetics of oseltamivir given orally in patients admitted into ICU for suspected or proven infection due to influenza A H1N1 2009 and to compare with data in healthy or not severely ill patients;Secondary Objective: NA
- Secondary Outcome Measures
Name Time Method