Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Candidemia Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

voriconazole (Vfend)

Drug

Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h

Notes:

  • If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
  • Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.

(IV = Intravenous; POS = Powder for oral suspension)

Other names: UK-109,496; Vfend; voriconazole

Primary outcomes

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

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

    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.

  2. Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration

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

  3. Time to Reach Cmax (Tmax) Following IV Administration

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

  4. AUC12,ss Following Oral Administration

    Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

    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.

  5. Cmax,ss Following Oral Administration

    Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

  6. Tmax Following Oral Administration

    Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

Secondary outcomes

  1. AUC12 Following IV Loading Dose

    Time frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

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

  2. Cmax Following an IV Loading Dose

    Time frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

  3. Tmax Following an IV Loading Dose

    Time frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

  4. Trough Concentrations (Cmin)

    Time frame: Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose

  5. AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

    Time frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

    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.

  6. Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

    Time frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

  7. Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

    Time frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

    Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.

  8. AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

    Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

    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.

  9. Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

    Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

  10. Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

    Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 22, 2008
Registry last updated
Jan 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.