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JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-111577

Registered date:

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied*Aspergillosis, Aspergilloma *Candidemia, Candidiasis *Cryptococcal Meningitis, Pulmonary Cryptococcosis *Fusariosis *Scedosporiosis
Date of first enrollment20/9/2011
Target sample size20
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : Voriconazole INN of the intervention : Voriconazole Dosage And administration of the intervention : *Children aged 2 to <12 yrs and 12 to <15 yrs weighing <50 kg: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 *Children aged 12 to <15 years weighing more than 50 kg: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. Control intervention name : null

Outcome(s)

Primary Outcome- Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] - Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] - Time to Reach Cmax (Tmax) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] - AUC12,ss Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdos ] - Cmax,ss Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdos ] - Tmax Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]
Secondary Outcome- Ratio of AUC12,ss Following IV Administration and AUC12,ss Following Oral Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] - AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] - Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] - Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] - AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ] - Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ] - Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]

Key inclusion & exclusion criteria

Age minimum2
Age maximum15
GenderBOTH
Include criteria- Male or female from 2 to <15 years of age. - Require treatment for the prevention of systemic fungal infection. - Expected to develop neutropenia (ANC <500 cells/uL) lasting more than 10 days following chemotherapy.
Exclude criteria- Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia. - Documented bacterial or viral infection not responding to appropriate treatment. - Hypersensitivity to or severe intolerance of azole antifungal agents. - Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.

Related Information

Contact

public contact
Name Pfizer Inc. Pfizer CT.gov Call Center
Address clinical-trials@pfizer.com
Telephone
E-mail
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scientific contact
Name Pfizer Inc. Pfizer CT.gov Call Center
Address clinical-trials@pfizer.com
Telephone
E-mail
Affiliation