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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


Phase 2
2 Years
11 Years
Not Enrolling
Both
Candidiasis, Candidemia

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration

Outcome Description:

AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.

Outcome Time Frame:

Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A1501088

NCT ID:

NCT00739934

Start Date:

December 2008

Completion Date:

October 2009

Related Keywords:

  • Candidiasis
  • Candidemia
  • Open-Label
  • Pharmacokinetics
  • Intravenous to oral switch
  • Safety
  • Voriconazole
  • Immunocompromise
  • Children
  • High Risk For Systemic Fungal Infection.
  • Candidiasis
  • Mycoses
  • Candidemia

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteBristol, Tennessee  37620