Pharmacokinetics of oseltamivir in patients with infection due to influenza A H1N1 2009 admitted in intensive care unit.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017350-13-BE

Enrollment

Registered

2009-11-17

Start date

2009-11-20

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe infection due to influenza A H1N1 MedDRA version: 12.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection

Interventions

Trade Name: Tamiflu® Product Name: Tamiflu® Pharmaceutical Form: Capsule*

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Adult patients or adolescents with body weight less than 45kg

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026