Influenza Clinical Trial
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)
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 infant's 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.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 11 Months |
Eligibility |
Inclusion Criteria: 1. Male or female study participants less than 12 months of age 2. Suspected or laboratory diagnosis of influenza 3. Treated with oseltamivir, rimantadine or amantadine Exclusion Criteria: None listed |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | The University of Texas Southwestern Medical Center | Dallas | Texas |
United States | University of Colorado | Denver | Colorado |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | Creighton University | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Oregon Health Sciences University | Portland | Oregon |
United States | Arkansas Children's Hospital | Pulaski | Arkansas |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | University of Utah | Salt Lake City | Utah |
United States | The University of Texas Health Science Center | San Antonio | Texas |
United States | Children's Hospital and Health Center | San Diego | California |
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States, Canada,
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