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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration

Outcome Description:

AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.

Outcome Time Frame:

Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A1501088

NCT ID:

NCT00739934

Start Date:

December 2008

Completion Date:

October 2009

Related Keywords:

• Candidiasis
• Candidemia
• Open-Label
• Pharmacokinetics
• Intravenous to oral switch
• Safety
• Voriconazole
• Immunocompromise
• Children
• High Risk For Systemic Fungal Infection.
• Candidiasis
• Mycoses
• Candidemia