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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Candidemia

Candidiasis

Treatments

Drug: voriconazole (Vfend)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00739934

A1501088

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

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.