NCT00739934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 25, 2011

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

10 months

First QC Date

August 20, 2008

Results QC Date

September 17, 2010

Last Update Submit

January 26, 2011

Conditions

CandidiasisCandidemia

Keywords

Open-LabelPharmacokineticsIntravenous to oral switchSafetyVoriconazoleImmunocompromiseChildrenHigh Risk For Systemic Fungal Infection.

Outcome Measures

Primary Outcomes (6)

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

    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.

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

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

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

  • Time to Reach Cmax (Tmax) Following IV Administration

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

  • AUC12,ss Following Oral Administration

    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.

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

  • Cmax,ss Following Oral Administration

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

  • Tmax Following Oral Administration

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

Secondary Outcomes (10)

  • AUC12 Following IV Loading Dose

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

  • Cmax Following an IV Loading Dose

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

  • Tmax Following an IV Loading Dose

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

  • Trough Concentrations (Cmin)

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

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

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

  • +5 more secondary outcomes

Study Arms (1)

Children aged 2 to <12 years

EXPERIMENTAL

Immunocompromised children aged 2 to \<12 years who are at high risk for systemic fungal infection.

Drug: voriconazole (Vfend)

Interventions

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: 1. 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. 2. 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)

Also known as: UK-109,496; Vfend; voriconazole
Children aged 2 to <12 years

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Pfizer Investigational Site

Tucson, Arizona, 85719, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85724, United States

Location

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32207, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30322-1062, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30322, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342-1600, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70118, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21215, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

CandidiasisCandidemia

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsCandidiasis, InvasiveInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 28, 2011

Results First Posted

January 25, 2011

Record last verified: 2011-01

Locations

US(14)