Status:
COMPLETED
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
Lead Sponsor:
Pfizer
Conditions:
Candidiasis
Candidemia
Eligibility:
All Genders
2-11 years
Phase:
PHASE2
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 sys...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00739934
Start Date
December 1 2008
End Date
October 1 2009
Last Update
January 28 2011
Active Locations (14)
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1
Pfizer Investigational Site
Tucson, Arizona, United States, 85719
2
Pfizer Investigational Site
Tucson, Arizona, United States, 85724
3
Pfizer Investigational Site
Orange, California, United States, 92868
4
Pfizer Investigational Site
Jacksonville, Florida, United States, 32207