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

Roche

Status and phase

Terminated

Phase 1

Conditions

Influenza

Treatments

Drug: Tamiflu

Study type

Interventional

Funder types

Industry

Identifiers

NCT01053663

NP25138

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

Under 365 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infant patients
Date of birth to date of enrollment is <1 year
Diagnosis of influenza
Duration of influenza symptoms </=96 hours prior to first dose
- 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