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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:3/30/2013
Start Date:January 2011
End Date:January 2013
Contact:Please reference Study ID Number: NP25138 www.roche.com/about_roche/roche_worldwide.htm
Email:genentechclinicaltrials@druginfo.com
Phone:888-662-6728 (U.S. Only)

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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


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.


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
We found this trial at
20
sites
604
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Park Ridge, IL
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808
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Ann Arbor, MI
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858
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Ashville, NC
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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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895
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Cleveland, OH
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349
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Dallas, TX
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1128
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Daytona Beach, FL
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249
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Fort Smith, AR
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643
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Indianapolis, IN
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657
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Louisville, KY
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630
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Milwaukee, WI
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1290
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New York, NY
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1202
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Newark, DE
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1278
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Newark, NJ
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1181
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Norfolk, VA
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262
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Omaha, NE
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190
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Overland Park, KS
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1318
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Santa Clara, CA
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1421
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from
Warwick, RI
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