23
Participants
Start Date
October 31, 2010
Primary Completion Date
May 31, 2013
Study Completion Date
June 30, 2013
voriconazole
"Subjects 12 - \<18 yrs (excluding subjects 12 - 14 yrs weighing \<50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h.~Subjects 2 - \<12 yrs, and subjects 12 - 14 weighing \<50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg).~Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days."
Department of Paediatrics and Adolescent Medicine, Hong Kong
Medical Research Laboratory Philippine General Hospital University of the Philippines, Ermita
Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila, Manila
Semmelweis Egyetem, II. sz. Szemeszeti Klinika, Budapest
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika, Budapest
Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet, Budapest
Beijing Children's Hospital, Capital University of Medical Sciences, Beijing
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan
Fakultni nemocnice Brno - Klinika detske onkologie, Brno
Queen Mary Hospital, Hong Kong
The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T.
Instituto Nacional de Pediatria, Colonia Insurgentes Cuicuilco, Delegacion Coyoacan
Oddzial Pediatryczny I- Hematologiczno-Onkologiczny, Olsztyn
Detska fakultna nemocnica s poliklinikou Bratislava, Bratislava
Lead Sponsor
Pfizer
INDUSTRY