Clinical trial NCT00739934: Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis
Candidemia
Keywords: Open-Label
Pharmacokinetics
Intravenous to oral switch
Safety
Voriconazole
Immunocompromise
Children
High Risk For Systemic Fungal Infection.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
timeFrame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
timeFrame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: Time to Reach Cmax (Tmax) Following IV Administration
timeFrame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: AUC12,ss Following Oral Administration
timeFrame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
measure: Cmax,ss Following Oral Administration
timeFrame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
measure: Tmax Following Oral Administration
timeFrame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Secondary outcomes:
measure: AUC12 Following IV Loading Dose
timeFrame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: Cmax Following an IV Loading Dose
timeFrame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: Tmax Following an IV Loading Dose
timeFrame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: Trough Concentrations (Cmin)
timeFrame: Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose
measure: AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
timeFrame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
timeFrame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
timeFrame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
measure: AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
timeFrame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
measure: Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
timeFrame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
measure: Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
timeFrame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: