Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311701
Status:
COMPLETED
Last Update Posted:
2011-05-13
First Post:
2006-04-05
Brief Title:
Chart Review of Antivirals for Influenza in Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Retrospective Chart Review to Assess the Safety of Oseltamivir Tamiflu Compared to Alternate Antiviral Therapy Amantadine or Rimantadine Administered to Children Less Than 12 Months of Age With Diagnosed or Suspected Influenza CASG 113
Status:
COMPLETED
Status Verified Date:
2007-10
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:
This retrospective study conducted in Canada and the US involves a chart review to assess the safety of oseltamivir Tamiflu compared to alternate antiviral therapy amantidine or rimantidine administered to children less than 12 months of age with diagnosed or suspected influenza The objectives are to describe the frequency of neurological and all other adverse events possibly related to administration of these antivirals in these infants Investigators will also compare frequency of adverse events at various doses of oseltamivir in these children Critical endpoints to be collected include frequency and severity of adverse events particularly those relating to central nervous system complications A sub-investigator will travel to each of the participating sites to collect data related to each infants health prior to becoming ill health status at time of influenza diagnosis dosing regimen reported neurological events post-dosing and all reported adverse events post-dosing
Detailed Description:
The study is a retrospective review of charts of children less than 12 months of age that were diagnosed with influenza and treated with oseltamivir The chart review will focus on assessment of neurological and other adverse events that may have been related to the administration of oseltamivir A control population will consist of children less than 12 months treated with either rimantadine or amantadine The administration of oseltamivir to children at high risk ie immunocompromised hosts less than 12 months old with influenza is frequently considered in medical practice despite the findings of neurotoxicity in a juvenile rat study Since oseltamivir is the only active treatment against H5N1 influenza strains it is imperative to understand the ramifications of its potential widespread use in very young infants in the event of an outbreak This study is designed to gather documented evidence by which the circumstances of use and defined outcomes can be described Patient selection will be made by review of hospital inpatient medical records emergency room medical records andor pharmacy records to identify patients less than 1 yr old dosed with oseltamivir suspension Redacting the charts will be done in a manner that will obscure personal health information individual identifiers without obscuring the necessary clinical data A separate research data collection form will be prepared on which critical information can be transcribed that would subsequently be available for analysis Critical information to be captured at the time of initiating oseltamivir treatment includes age birth history gender underlying medical conditions presenting influenza symptoms if done type of flu test and dose regime Critical endpoints to be collected will include the frequency and severity of adverse events particularly those relating to central nervous system complications
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 |
| CASG 113 | None | None | None |