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Trial record 12 of 13 for:    "Viral Infectious Disease" | "Amantadine"

Chart Review of Antivirals for Influenza in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311701
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : May 13, 2011
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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 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 or disease

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 (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.

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Study Type : Observational
Enrollment : 200 participants
Time Perspective: 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)
Study Start Date : November 2005
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311701

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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 Southwestern Medical Center
Dallas, Texas, United States, 75390-9063
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
The University of Texas Health Science Center
San Antonio, Texas, United States, 78229-3900
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

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Responsible Party: Robert Johnson, HHS/NIAID/DMID Identifier: NCT00311701     History of Changes
Other Study ID Numbers: 05-0111
CASG 113
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: October 2007
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Influenza, pediatric
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents