21
Participants
Start Date
September 30, 2011
Primary Completion Date
May 31, 2013
Study Completion Date
May 31, 2013
Voriconazole
"Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h.~Notes:~If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.~Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.~(IV = Intravenous; POS = Powder for oral suspension)"
Voriconazole
"Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h.~Notes:~If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.~Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.~(IV = Intravenous; POS = Powder for oral suspension)"
Japanese Red Cross Nagoya Daiichi Hospital, Nagoya
National hospital Organization Nagoya Medical Center, Nagoya
Sapporo Hokuyu Hosipital, Sapporo
Kanagawa Children's Medical Center, Yokohama
Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi
Dokkyo Medical University Hospital, Shimotsuga-gun
Lead Sponsor
Pfizer
INDUSTRY