Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391768
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2006-10-20
Brief Title:
Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A PharmacokineticPharmacodynamic and Safety Evaluation of Oseltamivir Tamiflu for the Treatment of Children Less Than 24 Months of Age With Confirmed Influenza Infection CASG 114
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn how to treat influenza in children less than 2 years of age Tamiflu the drug being studied is approved for treatment of children 1 year of age and older with influenza Researchers want to learn more about the activity of Tamiflu in the body to determine a dose of that is safe well-tolerated and effective in young children with influenza Children less than 24 months of age with confirmed influenza will receive Tamiflu 2 times a day for 5 days Older participants will be enrolled first and younger children will be enrolled after the safety data is reviewed for older participants Study procedures include blood samples swabs from inside the nose and body and nervous system evaluations Participants may be involved in study related procedures for up to 37 days
Detailed Description:
Oseltamivir is approved for prophylaxis and treatment of children 1 year of age and older with influenza Influenza treatments for children under the age of 1 year are needed because mortality from influenza is high among this age group even when there are no underlying medical conditions Oseltamivir is frequently used off-label in children less than 1 year of age with no data supporting the doses being used Given the risk of severe or fatal influenza infection in infants the lack of repeat dose pharmacokinetic PK data in children less than 2 the need for treatments in this population of children and the fact that oseltamivir is being used off-label in this population the current study will systematically study the PK and safety of oseltamivir in children less than 2 years of age with confirmed influenza to determine the appropriate dose to be used in these age groups This data will be critical to pediatricians caring for these potentially gravely ill infants This study is a prospective age-stratified PKpharmacodynamic PD and safety evaluation of oseltamivir therapy in children less than 24 months of age with confirmed influenza infection Participants will be stratified by age into the following enrollment scheme at study initiation 12-23 months Cohort I 9-11 months Cohort II 6-8 months Cohort III 3-5 months Cohort IV and 0-2 months Cohort V At study onset Cohort II and III will be enrolled simultaneously Cohorts IV and V will be enrolled sequentially by decreasing age groups predicated upon the PK and safety data from the preceding cohort In the event of a public health emergency the Data Safety Monitoring Board DSMB or Food and Drug Administration FDA may authorize the following modifications to the proposed enrollment plan the opening of younger age cohorts without the full dataset from the next higher age cohort the re-opening of previously closed cohorts to obtain additional data andor the over-enrollment of any of the 5 cohorts The oldest cohort Cohort I may be enrolled at any time during the study The primary study objective is to define the PK of oseltamivir and oseltamivir carboxylate in children with confirmed influenza less than 2 years of age The oseltamivir dose initially evaluated in Cohort I was the approved dose of 30 mg twice a day bid However the oseltamivir carboxylate area under the curve AUC12 values for 5 of the 9 subjects enrolled in Cohort I as of August 5 2009 were below the lower range utilized for the other cohorts in the study as was the GM AUC12 for Cohort I as a group 2589 nanograms per hour per milliliter ngxhmL As a consequence the DSMB recommended on August 5 2009 that the protocol be amended to utilize weight-based dosing of oseltamivir in subjects subsequently enrolled in Cohort I and to employ the targeted AUC approach used for Cohorts II-V for this cohort as well Based upon the PK data available as of that date the initial weight-based dose to be evaluated for Cohort I is 35 mgkg bid A dose of oseltamivir 3 mgkgdose orally bid for 5 days 10 doses will be administered to the first 9 subjects in each of Cohorts II-III Additional subjects may be enrolled if the target AUC12 range is not achieved The proposed dose for subjects enrolled in Cohorts IV and V will be 3 mgkgdose orally bid for 5 days 10 doses although this dose may be adjusted prior to opening Cohort IV or V based on the dose required to achieve the target oseltamivir carboxylate AUC12 range in the previous cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01AI30025C | None | None | None |
| Roche WP-20749 CASG 114 | None | None | None |