Conditions: Influenza
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 65
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: infants 3 to \<12 months arm 2: infants 1 to \<3 months of age arm 3: infants 0 to 30 days (post natal) of age

Interventions: intervention 1: Tamiflu
Intervention descriptions: intervention 1: oral repeating dose

Protocol document: