A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection

An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) in the Treatment of Infants 0 to <12 Months of Age With Confirmed Influenza Infection

This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.

Inclusion Criteria:

• infants </=12 months of age
• laboratory confirmed diagnosis of influenza within 96 hours prior to first dose
• influenza symptoms for </=96 hours prior to first dose

Exclusion Criteria:

• preterm infants less than 40 weeks (corrected for gestational age)
• weight less than 5th percentile for age (corrected for gestational age)
• concurrent gastrointestinal conditions that preclude enteric absorption of the drug
• bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrollment
• active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease at baseline
• symptomatic inborn errors of metabolism