Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis; Candidemia
Intervention: voriconazole (Vfend) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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 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.
Clinical Details
Official title: An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To <12 Years Who Are At High Risk For Systemic Fungal Infection
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV AdministrationPeak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration Time to Reach Cmax (Tmax) Following IV Administration AUC12,ss Following Oral Administration Cmax,ss Following Oral Administration Tmax Following Oral Administration
Secondary outcome: AUC12 Following IV Loading DoseCmax Following an IV Loading Dose Tmax Following an IV Loading Dose Trough Concentrations (Cmin) AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Eligibility
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, Tucson, Arizona 85719, United States
Pfizer Investigational Site, Tucson, Arizona 85724, United States
Pfizer Investigational Site, Orange, California 92868, United States
Pfizer Investigational Site, Jacksonville, Florida 32207, United States
Pfizer Investigational Site, Atlanta, Georgia 30322-1062, United States
Pfizer Investigational Site, Atlanta, Georgia 30322, United States
Pfizer Investigational Site, Atlanta, Georgia 30342-1600, United States
Pfizer Investigational Site, New Orleans, Louisiana 70118, United States
Pfizer Investigational Site, Baltimore, Maryland 21215, United States
Pfizer Investigational Site, Durham, North Carolina 27710, United States
Pfizer Investigational Site, Cleveland, Ohio 44106, United States
Pfizer Investigational Site, Portland, Oregon 97239, United States
Pfizer Investigational Site, Nashville, Tennessee 37232, United States
Pfizer Investigational Site, Houston, Texas 77030, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 2008
Last updated: January 26, 2011
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