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

Roche

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Drug: Tamiflu

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988325

WP22849

2009-014365-12

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Oseltamivir 3 mg

Experimental group

Description:

infants 3 to \<12 months

Treatment:

Drug: Tamiflu

Oseltamivir 2.5 mg

Experimental group

Description:

infants 1 to \<3 months of age

Treatment:

Drug: Tamiflu

Oseltamivir 2 mg

Experimental group

Description:

infants 0 to 30 days (post natal) of age

Treatment:

Drug: Tamiflu