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A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza - NCT01053663-02111(Clinical Trial 664977)



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City:  Boston
State:  
MA
Zip Code: 02111
Conditions: Influenza
Purpose: 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.
Study summary:
Criteria: 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
Study is available at:
Boston, MA 02111
United States

Primary Contact:
Please reference Study ID Number: NP25138
Email: genentechclinicaltrials@druginfo.com
Phone: 888-662-6728 (U.S. Only)
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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