Chart Review of Antivirals for Influenza in Infants

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00311701
• Collaborator: (none)
• Enrollment: 200
• Locations: 16
• Duration (Months): 13
• Patients Per Site: 12.5
• Patients Per Site Per Month: 1

Study Details

Study Description

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	Intervention/Treatment	Phase
Influenza

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.

Study Design

• Study Type: Observational
• 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: Nov 1, 2005
• Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 11 Months
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233-0011
2	Arkansas Children's Hospital	Pulaski	Arkansas	United States	72202
3	Children's Hospital of Orange County	Orange	California	United States	92868
4	Children's Hospital and Health Center	San Diego	California	United States	92123
5	University of Colorado	Denver	Colorado	United States	80218
6	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
7	Creighton University	Omaha	Nebraska	United States	68198-2162
8	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
9	Oregon Health Sciences University	Portland	Oregon	United States	97201-3098
10	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
11	The University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390-9063
12	Cook Children's Medical Center	Fort Worth	Texas	United States	76104
13	The University of Texas Health Science Center	San Antonio	Texas	United States	78229-3900
14	University of Utah	Salt Lake City	Utah	United States	84132
15	Seattle Children's Hospital	Seattle	Washington	United States	98105
16	University of Alberta	Edmonton	Alberta	Canada	T6G 2B7

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00311701
• Other Study ID Numbers: 05-0111; CASG 113; N01AI30025C
• First Posted: Apr 6, 2006
• Last Update Posted: May 13, 2011
• Last Verified: Oct 1, 2007

• Keywords provided by , ,: Influenza, pediatric
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of May 13, 2011