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

Phase 2

Completed

• Conditions: Candidiasis; Candidemia
• Interventions: Drug: voriconazole (Vfend)

• Registration Number: NCT00739934
• Lead Sponsor: Pfizer

Brief Summary

In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Study Start: 2008-12
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-09-17
• Status Verified: 2011-01
• Results First Submitted QC: 2011-01-06
• Results First Posted: 2011-01-25
• Last Update Submitted: 2011-01-26
• Last Update Posted: 2011-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children aged 2 to <12 years	voriconazole (Vfend)	Immunocompromised children aged 2 to \<12 years who are at high risk for systemic fungal infection.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration	Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	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.
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration	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	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	Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose	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.
Cmax,ss Following Oral Administration	Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Tmax Following Oral Administration	Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

Secondary Outcome Measures

Name	Time	Method
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration	Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
AUC12 Following IV Loading Dose	Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.
Cmax Following an IV Loading Dose	Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Tmax Following an IV Loading Dose	Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Trough Concentrations (Cmin)	Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration	Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	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.
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration	Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration	Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose	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.
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration	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	Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Houston, Texas, United States