Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
Completed · Phase 2
Conditions studied: Candidiasis, Candidemia
In brief
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.
Key facts
- Study ID
- NCT00739934
- Run by
- Pfizer
- People needed
- 40
- Starts
- 2008-12-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2011-01-28
Who can join
Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Tucson, Arizona, United States
- Pfizer Investigational Site — Tucson, Arizona, United States
- Pfizer Investigational Site — Orange, California, United States
- Pfizer Investigational Site — Jacksonville, Florida, United States
- Pfizer Investigational Site — Atlanta, Georgia, United States
- Pfizer Investigational Site — Atlanta, Georgia, United States
- Pfizer Investigational Site — Atlanta, Georgia, United States
- Pfizer Investigational Site — New Orleans, Louisiana, United States
- Pfizer Investigational Site — Baltimore, Maryland, United States
- Pfizer Investigational Site — Durham, North Carolina, United States
- Pfizer Investigational Site — Cleveland, Ohio, United States
- Pfizer Investigational Site — Portland, Oregon, United States
- Pfizer Investigational Site — Nashville, Tennessee, United States
- Pfizer Investigational Site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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