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Completed No phase listed Observational

Chart Review of Antivirals for Influenza in Infants

ClinicalTrials.gov ID: NCT00311701

Public ClinicalTrials.gov record NCT00311701. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 12:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00311701
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
200 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range
Up to 11 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2005 (Type not available)
Primary completion
Not listed
Completion
Dec 2006 (Type not available)
Last update posted
May 13, 2011

2005 – 2006

United States locations

U.S. sites
15
U.S. states
12
U.S. cities
15
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233-0011 —
Arkansas Children's Hospital Pulaski Arkansas 72202 —
Children's Hospital of Orange County Orange California 92868 —
Children's Hospital and Health Center San Diego California 92123 —
University of Colorado Denver Colorado 80218 —
Washington University in St. Louis St Louis Missouri 63110 —
Creighton University Omaha Nebraska 68198-2162 —
MetroHealth Medical Center Cleveland Ohio 44109 —
Oregon Health Sciences University Portland Oregon 97201-3098 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
The University of Texas Southwestern Medical Center Dallas Texas 75390-9063 —
Cook Children's Medical Center Fort Worth Texas 76104 —
The University of Texas Health Science Center San Antonio Texas 78229-3900 —
University of Utah Salt Lake City Utah 84132 —
Seattle Children's Hospital Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00311701, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2011 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00311701 live on ClinicalTrials.gov.

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