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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Tamiflu (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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.

Clinical Details

Official title: An Open-label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir in the Treatment of Infants Less Than One Year of Age With Influenza Infection

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate

Safety Profile: AEs, vital signs, laboratory parameters

Secondary outcome:

Viral load and shedding

Development of resistance to oseltamivir


Minimum age: N/A. Maximum age: 365 Days. Gender(s): Both.


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

Locations and Contacts

Petach Tikva 49100, Israel

Little Rock, Arkansas 45229-3039, United States

Los Angeles, California 90095, United States

Oakland, California 94609-1809, United States

Orange, California 92868, United States

San Diego, California 92123, United States

Aurora, Colorado 80045, United States

Wilmington, Delaware 19803, United States

Jacksonville, Florida 32209, United States

Chicago, Illinois 60611, United States

South Bend, Indiana 46601, United States

Wichita, Kansas 67214, United States

Louisville, Kentucky 40202, United States

Boston, Massachusetts 02115, United States

Boston, Massachusetts 02111, United States

Boston, Massachusetts 02118, United States

Springfield, Massachusetts 01199, United States

Detroit, Michigan 48201, United States

Omaha, Nebraska 68131, United States

Syracuse, Nevada 13210, United States

Morristown, New Jersey 07960, United States

New Brunswick, New Jersey 08901, United States

Bronx, New York 10461, United States

Brooklyn, New York 11203, United States

New York, New York 10016, United States

Stony Brook, New York 11794, United States

Durham, North Carolina 27705, United States

Raleigh, North Carolina 27610, United States

Akron, Ohio 44308-1062, United States

Cleveland, Ohio 44106, United States

Dayton, Ohio 45404, United States

Toledo, Ohio 43606, United States

Toledo, Ohio 43608, United States

Providence, Rhode Island 02903, United States

Austin, Texas 78723, United States

Dallas, Texas 75390, United States

Houston, Texas 77030, United States

Richmond, Virginia 23219, United States

Madison, Wisconsin 53792, United States

Additional Information

Starting date: January 2011
Last updated: May 13, 2013

Page last updated: August 23, 2015

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