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) |
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
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