Chart Review of Antivirals for Influenza in Infants

Completed

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00311701

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

200

Starts

2005-11-01

Expected to finish

2006-12-01

Last updated by the study team

2011-05-13

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female study participants less than 12 months of age
• Suspected or laboratory diagnosis of influenza
• Treated with oseltamivir, rimantadine or amantadine

You may not qualify if…

• None listed

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Pulaski, Arkansas, United States
• Children's Hospital of Orange County — Orange, California, United States
• Children's Hospital and Health Center — San Diego, California, United States
• University of Colorado — Denver, Colorado, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Creighton University — Omaha, Nebraska, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• The University of Texas Health Science Center — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• University of Alberta — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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