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

Stopped early · Phase 1

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01053663

Run by

Hoffmann-La Roche

People needed

9

Starts

2011-01-01

Expected to finish

2013-01-01

Last updated by the study team

2016-07-27

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Wilmington, Delaware, United States
• Study site — Jacksonville, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — South Bend, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Morristown, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — New York, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — Syracuse, New York, United States
• Study site — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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