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

Completed · Phase 1/Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00391768

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

87

Starts

2007-01-01

Expected to finish

2010-04-01

Last updated by the study team

2013-05-01

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent from parent(s) or legal guardian(s).
• Age:
• Cohort I: 12 - 23 mo. Cohort II: 9 - 11 mo. Cohort III: 6 - 8 mo. Cohort IV: 3 - 5 mo. Cohort V: 0 - 2 mo.
• Confirmed laboratory diagnosis of influenza by viral culture or rapid influenza diagnostic test within 96 hours prior to study enrollment.
• Duration of influenza symptoms less than or equal to 96 hours.

You may not qualify if…

• Concomitant vomiting illness that would preclude ability to take drug.
• Immunocompromised subject (e.g., malignancy, congenital agammaglobulinemia, HIV).
• Documented renal impairment (e.g., polycystic renal disease, nephrectomy, renal transplantation, renal agenesis, dialysis requirement, renal failure, nephrotic syndrome at any time prior to enrollment, current receipt of diuretic therapy).
• Documented hepatic impairment (e.g., congenital hepatitis, biliary atresia, cholelithiasis).
• Gastrointestinal abnormality which might hinder absorption of an oral medication.
• Current receipt of inotropic drugs (e.g., epinephrine, norepinephrine, dopamine, dobutamine).
• History of seizures.
• Documented congenital malformations of the central nervous system defined at birth (e.g., hydranencephaly, prosencephaly, spina bifida).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital - Infectious Diseases — Little Rock, Arkansas, United States
• Miller Children's Hospital Long Beach - Bickerstaff Family Center — Long Beach, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Children's Hospital Colorado - Infectious Disease — Aurora, Colorado, United States
• Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease — Washington D.C., District of Columbia, United States
• University of Florida - Shands Children's Hospital — Gainesville, Florida, United States
• University of South Florida - Tampa General Hospital - Pediatrics — Tampa, Florida, United States
• Emory Children's Center - Pediatric Infectious Diseases — Atlanta, Georgia, United States
• Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases — Atlanta, Georgia, United States
• Louisiana State University Health Shreveport - Pediatrics — Shreveport, Louisiana, United States
• University of Mississippi - Children's Infectious Diseases — Jackson, Mississippi, United States
• Washington University School of Medicine in St. Louis - Center for Clinical Studies — St Louis, Missouri, United States
• University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases — Omaha, Nebraska, United States
• Cohen Children's Medical Center - Pediatric Infectious Diseases — Manhasset, New York, United States
• University of Rochester — Rochester, New York, United States
• SUNY Upstate Medical University Hospital - Pediatrics — Syracuse, New York, United States
• Cincinnati Children's Hospital Medical Center - Infectious Diseases — Cincinnati, Ohio, United States
• MetroHealth Medical Center - Pediatric Infectious Disease — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia - The Center for Pediatric Clinical Effectiveness — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC - General Academic Pediatric — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital - Pediatrics — Providence, Rhode Island, United States
• Vanderbilt University - Pediatric - Infectious Diseases — Nashville, Tennessee, United States
• Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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