Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00739934
• Date of registration: 20/08/2008
• Primary sponsor: Pfizer
• Public title: Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
• Scientific title: An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To <12 Years Who Are At High Risk For Systemic Fungal Infection
• Date of first enrolment: December 2008
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00739934
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female from 2 to <12 years of age.

- Require treatment for the prevention of systemic fungal infection.

- Expected to develop neutropenia (ANC <500 cells/µL) lasting more than 10 days
following chemotherapy.

- Anticipated to live for more than 3 months.

Exclusion 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.



Age minimum: 2 Years
Age maximum: 11 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Candidemia

Candidiasis

Intervention(s)

Drug: voriconazole (Vfend)

Primary Outcome(s)

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration [Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 138 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 postdose]

Cmax,ss Following Oral Administration [Time Frame: Day 7 (or later) predose, 1, 2, 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 138 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 138 minutes, 4, 6, 8 and 12 hours postdose]

Tmax Following Oral Administration [Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose]

Secondary Outcome(s)

AUC12 Following IV Loading Dose [Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose]

AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [Time Frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 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 Following an IV Loading Dose [Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose]

Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [Time Frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 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 Following an IV Loading Dose [Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose]

Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [Time Frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 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]

Trough Concentrations (Cmin) [Time Frame: Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose]

Secondary ID(s)

A1501088

Source(s) of Monetary Support

Please refer to primary and secondary sponsors