87
Participants
Start Date
January 31, 2007
Primary Completion Date
March 31, 2010
Study Completion Date
April 30, 2010
oseltamivir (Tamiflu®)
Oseltamivir is supplied as a white powder blend for constitution to a suspension. It is supplied in 100 ml amber glass bottles with 30 grams of powder for oral suspension, a plastic adapter, a plastic oral dispenser and a plastic measuring cup. Initially subjects in Cohort I received oseltamivir 30 mg orally twice daily for 5 days. The DSMB recommended on 05-Aug-2009 that weight based dosing of oseltamivir for subjects subsequently enrolled in Cohort I. Based on pharmacokinetic data available as of that date, the initial weight-based dose to be evaluated for Cohort I is 3.5 mg/kg twice a day. Cohort II and Cohort III will receive oseltamivir at 3.0 mg/kg/dose orally twice daily for 5 days. Cohorts IV and V will receive 3.0 mg/kg/dose orally twice daily for 5 days, this dose may be adjusted.
University of Rochester, Rochester
Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases, Atlanta
University of Alabama at Birmingham, Birmingham
Arkansas Children's Hospital - Infectious Diseases, Little Rock
Miller Children's Hospital Long Beach - Bickerstaff Family Center, Long Beach
Children's Hospital of Orange County, Orange
Rady Children's Hospital San Diego, San Diego
Children's Hospital Colorado - Infectious Disease, Aurora
Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease, Washington D.C.
University of Florida - Shands Children's Hospital, Gainesville
University of South Florida - Tampa General Hospital - Pediatrics, Tampa
Emory Children's Center - Pediatric Infectious Diseases, Atlanta
Louisiana State University Health Shreveport - Pediatrics, Shreveport
University of Mississippi - Children's Infectious Diseases, Jackson
Washington University School of Medicine in St. Louis - Center for Clinical Studies, St Louis
University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases, Omaha
Cohen Children's Medical Center - Pediatric Infectious Diseases, Manhasset
SUNY Upstate Medical University Hospital - Pediatrics, Syracuse
Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati
MetroHealth Medical Center - Pediatric Infectious Disease, Cleveland
Children's Hospital of Philadelphia - The Center for Pediatric Clinical Effectiveness, Philadelphia
Children's Hospital of Pittsburgh of UPMC - General Academic Pediatric, Pittsburgh
Rhode Island Hospital - Pediatrics, Providence
Vanderbilt University - Pediatric - Infectious Diseases, Nashville
Parkland Memorial Hospital, Dallas
The University of Texas Southwestern Medical Center, Dallas
Cook Children's Infectious Disease Services, Fort Worth
University of Utah - Pediatric Pharmacology Program, Salt Lake City
Seattle Children's Hospital - Infectious Diseases, Seattle
University of Alberta Hospital - Pediatrics, Edmonton
The Hospital for Sick Children - Infectious Diseases, Toronto
Centre Hospitalier de l'Universite Laval/ CHUQ, Québec
National Institute of Allergy and Infectious Diseases (NIAID)
NIH