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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00311701 |
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.
Condition |
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Influenza |
Study Type: | Observational |
Study Design: | Retrospective |
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) |
Estimated Enrollment: | 200 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2006 |
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 (i.e. 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 and/or 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.
Ages Eligible for Study: | up to 11 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
None listed
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35233-0011 | |
United States, Arkansas | |
Arkansas Children's Hospital | |
Pulaski, Arkansas, United States, 72202 | |
United States, California | |
Children's Hospital of Orange County | |
Orange, California, United States, 92868 | |
Children's Hospital and Health Center | |
San Diego, California, United States, 92123 | |
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80218 | |
United States, Missouri | |
Washington University in St. Louis | |
Saint Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Creighton University | |
Omaha, Nebraska, United States, 68198-2162 | |
United States, Ohio | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109 | |
United States, Oregon | |
Oregon Health Sciences University | |
Portland, Oregon, United States, 97201-3098 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
The University of Texas Health Science Center | |
San Antonio, Texas, United States, 78229-3900 | |
The University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390-9063 | |
Cook Children's Medical Center | |
Fort Worth, Texas, United States, 76104 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 | |
United States, Washington | |
Children's Hospital and Regional Medical Center | |
Seattle, Washington, United States, 98105 | |
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2B7 |
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 05-0111, CASG 113 |
Study First Received: | April 5, 2006 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00311701 History of Changes |
Health Authority: | United States: Federal Government |
Influenza, pediatric |
Virus Diseases Anti-Infective Agents Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Orthomyxoviridae Infections Amantadine Antiviral Agents Oseltamivir |
Virus Diseases Anti-Infective Agents RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections |
Therapeutic Uses Influenza, Human Orthomyxoviridae Infections Antiviral Agents Pharmacologic Actions |