Chart Review of Antivirals for Influenza in Infants

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00311701
First received: April 5, 2006
Last updated: May 12, 2011
Last verified: October 2007
  Purpose

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
Influenza

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 200
Study Start Date: November 2005
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   up to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311701

Locations
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
  More Information

No publications provided

Responsible Party: Robert Johnson, HHS/NIAID/DMID
ClinicalTrials.gov Identifier: NCT00311701     History of Changes
Other Study ID Numbers: 05-0111, CASG 113, N01AI30025C
Study First Received: April 5, 2006
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Influenza, pediatric

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014