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

NCT ID: NCT01383993

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-05-31

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.

Conditions

Aspergillosis, Aspergilloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1.0

Immunocompromised children aged 2 to \<15 and 12 to \<15 years weighing \<50 kg who are at high risk for systemic fungal infection.

Group Type: EXPERIMENTAL

Voriconazole

Intervention Type: DRUG

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.

Notes:

If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.

Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.

(IV = Intravenous; POS = Powder for oral suspension)

2.0

Immunocompromised children aged 12 to \<15 years weighing more than 50 kg who are at high risk for systemic fungal infection.

Group Type: EXPERIMENTAL

Voriconazole

Intervention Type: DRUG

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.

Notes:

If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.

Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.

(IV = Intravenous; POS = Powder for oral suspension)

Interventions

Voriconazole

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.

Notes:

If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.

Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.

(IV = Intravenous; POS = Powder for oral suspension)

Intervention Type: DRUG

Voriconazole

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.

Notes:

If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.

Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.

(IV = Intravenous; POS = Powder for oral suspension)

Intervention Type: DRUG

Other Intervention Names

UK-109,496; Vfend; Voriconazole; UK-109,496; Vfend; Voriconazole

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Japanese Red Cross Nagoya Daiichi Hospital

Nagoya, Aichi-ken, Japan

National hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Sapporo Hokuyu Hosipital

Sapporo, Hokkaido, Japan

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan

Osaka Medical Center and Research Institute for Maternal and Child Health

Izumi, Osaka, Japan

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, Japan

Countries

Japan

References

Mori M, Kobayashi R, Kato K, Maeda N, Fukushima K, Goto H, Inoue M, Muto C, Okayama A, Watanabe K, Liu P. Pharmacokinetics and safety of voriconazole intravenous-to-oral switch regimens in immunocompromised Japanese pediatric patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1004-13. doi: 10.1128/AAC.04093-14. Epub 2014 Dec 1.

Reference Type: DERIVED

PMID: 25451051 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501096&StudyName=Study%20Of%20The%20Pharmacokinetics%20And%20Safety%20Of%20Voriconazole%20In%20Children%202%20To%20Less%20Than%2015%20Years%20Old%20Who%20Are%20At%20High%20Risk%20For%20System

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Other Identifiers

A1501096

Identifier Type: -

Identifier Source: org_study_id