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 |
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.
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
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