31
Participants
Start Date
May 31, 2009
Primary Completion Date
May 31, 2013
Study Completion Date
May 31, 2013
Voriconazole
"All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy.~Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (\<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator.~Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing \<50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension."
Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Patumwan
Department of Pediatrics, Phramongkutklao hospital, Rajathevee
Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok Noi
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
Children's Pavilion, Virginia Commonwealth University Health System, Richmond
Pediatric Hematology and Oncology, Virginia Commonwealth University Health System, Richmond
Virginia Commonwealth University/MCV Clinical Pathology, Richmond
Virginia Commonwealth University, Richmond
HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia, Madrid
Hospital Universitario 12 de Octubre, Madrid
Fakultni nemocnice Brno, Brno
The University of Texas MD Anderson Cancer Center, Houston
Childrens Hospital Los Angeles, Los Angeles
Children's Hospital & Research Center Oakland (CHRCO), Oakland
National University Hospital, Singapore
KK Women's and Children's Hospital, Singapore
Virginia Commonwealth University Health System, Hospital Pharmacy, Richmond
Alberta Children's Hospital, Pediatric Oncology Office, Calgary
Alberta Children's Hospital, Calgary
Fakultni nemocnice Brno, Brno
UMC St. Radboud, Nijmegen
Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej, Wroclaw
Hospital General Universitari Vall D'Hebron, Barcelona
Hospital Universitari Vall d'Hebron. Servicio de Farmacia, Barcelona
Hospital Universitario Vall d'Hebron, Barcelona
Lead Sponsor
Pfizer
INDUSTRY