Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn how to treat influenza in children less than 2 years of age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age and older with influenza. Researchers want to learn more about the activity of Tamiflu® in the body to determine a dose of that is safe, well-tolerated, and effective in young children with influenza. Children less than 24 months of age with confirmed influenza will receive Tamiflu® 2 times a day for 5 days. Older participants will be enrolled first and younger children will be enrolled after the safety data is reviewed for older participants. Study procedures include blood samples, swabs from inside the nose, and body and nervous system evaluations. Participants may be involved in study related procedures for up to 37 days.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• Signed informed consent from parent(s) or legal guardian(s).

• Age:

Cohort I: 12 - 23 mo. Cohort II: 9 - 11 mo. Cohort III: 6 - 8 mo. Cohort IV: 3 - 5 mo. Cohort V: 0 - 2 mo.

• Confirmed laboratory diagnosis of influenza by viral culture or rapid influenza diagnostic test within 96 hours prior to study enrollment.

• Duration of influenza symptoms less than or equal to 96 hours.

Exclusion Criteria:

• Concomitant vomiting illness that would preclude ability to take drug.

• Immunocompromised subject (e.g., malignancy, congenital agammaglobulinemia, HIV).

• Documented renal impairment (e.g., polycystic renal disease, nephrectomy, renal transplantation, renal agenesis, dialysis requirement, renal failure, nephrotic syndrome at any time prior to enrollment, current receipt of diuretic therapy).

• Documented hepatic impairment (e.g., congenital hepatitis, biliary atresia, cholelithiasis).

• Gastrointestinal abnormality which might hinder absorption of an oral medication.

• Current receipt of inotropic drugs (e.g., epinephrine, norepinephrine, dopamine, dobutamine).

• History of seizures.

• Documented congenital malformations of the central nervous system defined at birth (e.g., hydranencephaly, prosencephaly, spina bifida).