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Completed Phase 1Phase 2 Interventional Results available

Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza

ClinicalTrials.gov ID: NCT00391768

Public ClinicalTrials.gov record NCT00391768. 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 19, 2026, 1:35 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 Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) for the Treatment of Children Less Than 24 Months of Age With Confirmed Influenza Infection (CASG 114)

Brief summary

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

The purpose of this study is to learn how to treat influenza in children less than 2 years of age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age and older with influenza. Researchers want to learn more about the activity of Tamiflu® in the body to determine a dose of that is safe, well-tolerated, and effective in young children with influenza. Children less than 24 months of age with confirmed influenza will receive Tamiflu® 2 times a day for 5 days. Older participants will be enrolled first and younger children will be enrolled after the safety data is reviewed for older participants. Study procedures include blood samples, swabs from inside the nose, and body and nervous system evaluations. Participants may be involved in study related procedures for up to 37 days.

Study identification

NCT ID
NCT00391768
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
87 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 23 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
Jan 2007 (Type not available)
Primary completion
Mar 2010 (Actual)
Completion
Apr 2010 (Actual)
Last update posted
May 1, 2013

2007 – 2010

United States locations

U.S. sites
29
U.S. states
19
U.S. cities
27
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35117 —
Arkansas Children's Hospital - Infectious Diseases Little Rock Arkansas 72202-3500 —
Miller Children's Hospital Long Beach - Bickerstaff Family Center Long Beach California 90806-1701 —
Children's Hospital of Orange County Orange California 92868-3835 —
Rady Children's Hospital San Diego San Diego California 92123-4223 —
Children's Hospital Colorado - Infectious Disease Aurora Colorado 80045-7106 —
Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease Washington D.C. District of Columbia 20010-2916 —
University of Florida - Shands Children's Hospital Gainesville Florida 32610-0296 —
University of South Florida - Tampa General Hospital - Pediatrics Tampa Florida 33606-3438 —
Emory Children's Center - Pediatric Infectious Diseases Atlanta Georgia 30322-1014 —
Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases Atlanta Georgia 30322 —
Louisiana State University Health Shreveport - Pediatrics Shreveport Louisiana 71103-4228 —
University of Mississippi - Children's Infectious Diseases Jackson Mississippi 39216-4505 —
Washington University School of Medicine in St. Louis - Center for Clinical Studies St Louis Missouri 63110-1010 —
University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases Omaha Nebraska 68114-4108 —
Cohen Children's Medical Center - Pediatric Infectious Diseases Manhasset New York 11030-3816 —
University of Rochester Rochester New York 14642 —
SUNY Upstate Medical University Hospital - Pediatrics Syracuse New York 13210-2342 —
Cincinnati Children's Hospital Medical Center - Infectious Diseases Cincinnati Ohio 45229-3026 —
MetroHealth Medical Center - Pediatric Infectious Disease Cleveland Ohio 44109-1998 —
Children's Hospital of Philadelphia - The Center for Pediatric Clinical Effectiveness Philadelphia Pennsylvania 19104-3309 —
Children's Hospital of Pittsburgh of UPMC - General Academic Pediatric Pittsburgh Pennsylvania 15213-3205 —
Rhode Island Hospital - Pediatrics Providence Rhode Island 02903-4923 —
Vanderbilt University - Pediatric - Infectious Diseases Nashville Tennessee 37232-0011 —
Parkland Memorial Hospital Dallas Texas 75235-7708 —
The University of Texas Southwestern Medical Center Dallas Texas 75390-9063 —
Cook Children's Infectious Disease Services Fort Worth Texas 76104-2710 —
University of Utah - Pediatric Pharmacology Program Salt Lake City Utah 84108-1457 —
Seattle Children's Hospital - Infectious Diseases Seattle Washington 98105-3901 —

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 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00391768, 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 1, 2013 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00391768 live on ClinicalTrials.gov.

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