A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:1 - 12
Updated:4/21/2016
Start Date:December 2010
End Date:July 2012

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An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of
intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2
years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10
doses). For patients whose conditions no longer merit continued iv dosing, therapy may be
switched to oral Tamiflu to complete their prescribed course of treatment. If medically
necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days.
Anticipated time on study treatment is 5 to 10 days.


Inclusion Criteria:

- children, 1-12 years of age

- diagnosis of influenza

- duration of influenza symptoms
Exclusion Criteria:

- evidence of severe hepatic decompensation

- patients taking probenecid within 1 week prior to first dose of study drug
We found this trial at
34
sites
Springfield, Massachusetts 01199
1364
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Springfield, MA
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898
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Akron, OH
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402
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Aurora, CO
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1444
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Boston, MA
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1291
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Bronx, NY
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1287
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Brooklyn, NY
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Charleston, South Carolina 29412
1064
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Charleston, SC
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610
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Chicago, IL
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895
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Cleveland, OH
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746
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Dayton, OH
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841
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Detroit, MI
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689
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Duluth, MN
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1051
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Durham, NC
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569
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Houston, TX
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1053
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Jacksonville, FL
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1168
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Los Angeles, CA
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657
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Louisville, KY
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574
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Madison, WI
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1262
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Morristown, NJ
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1290
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New York, NY
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1331
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Oakland, CA
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158
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Oklahoma City, OK
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262
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Omaha, NE
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6730
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Petach Tikva,
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1424
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Providence, RI
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1064
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Raleigh, NC
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1111
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Richmond, VA
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671
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South Bend, IN
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1358
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from
Stony Brook, NY
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1193
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from
Syracuse, NY
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805
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from
Toledo, OH
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1065
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Tyrone, PA
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27
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from
Wichita, KS
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1205
mi
from
Wilmington, DE
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