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

Phase 2

Completed

• Conditions: Aspergillosis, Aspergilloma
• Interventions: Drug: Voriconazole

• Registration Number: NCT01383993
• 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 less than 15 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: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-09
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-04
• Results First Submitted: 2014-04-07
• Results First Submitted QC: 2014-04-08
• Last Update Submitted: 2014-04-08
• Results First Posted: 2014-05-09
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion 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.
• 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
1.0	Voriconazole	Immunocompromised children aged 2 to \<15 and 12 to \<15 years weighing \<50 kg who are at high risk for systemic fungal infection.
2.0	Voriconazole	Immunocompromised children aged 12 to \<15 years weighing more than 50 kg who are at high risk for systemic fungal infection.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion	AUC12,ss was obtained by the Linear/Log trapezoidal method.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing	AUC12,ss was obtained by the Linear/Log trapezoidal method.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Number of Participants Assessed Near Distance Visual Acuity Test	Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit
Number of Participants Assessed Color Vision Test	Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit
Number of Participants Assessed Visual Questionnaire	Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit

Secondary Outcome Measures

Name	Time	Method
Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration	AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.	Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration
Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion	AUC12,ss was obtained by the Linear/Log trapezoidal method.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing	AUC12,ss was obtained by the Linear/Log trapezoidal method.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

Trial Locations

Locations (6)

Japanese Red Cross Nagoya Daiichi Hospital; 🇯🇵 Nagoya, Aichi, Japan

Kanagawa Children's Medical Center; 🇯🇵 Yokohama, Kanagawa, Japan

Sapporo Hokuyu Hosipital; 🇯🇵 Sapporo, Hokkaido, Japan

Dokkyo Medical University Hospital; 🇯🇵 Shimotsuga-gun, Tochigi, Japan

National hospital Organization Nagoya Medical Center; 🇯🇵 Nagoya, Aichi, Japan

Osaka Medical Center and Research Institute for Maternal and Child Health; 🇯🇵 Izumi, Osaka, Japan