Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Aspergillosis, Aspergilloma
Interventions
DRUG

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)"

DRUG

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)"

Trial Locations (6)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01383993 - Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection | Biotech Hunter | Biotech Hunter