A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days. Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• Infant patients

• Date of birth to date of enrollment is <1 year

• Diagnosis of influenza

• Duration of influenza symptoms
• - Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug)

Exclusion Criteria:

• Date of conception to date of birth + date of birth to enrollment is <36 weeks

• Creatinine clearance <30 mL/min/1.73m2

• Patients receiving any form of renal replacement therapy at baseline

• Clinical evidence of severe hepatic decompensation at the time of enrollment

• Patients taking probenecid medication within 1 week prior to study day 1 or during the study