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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Voriconazole

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.