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Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Scedosporium Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on
Scedosporisis.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus,
Candidasis,Cryptococcal infections not involving Scedosporisis.

NCT01660334
Pfizer
Completed
Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)

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Descriptive Information
Brief TitleVoriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)
Official TitleSpecial Investigation of Vfend on Scedosporisis
Brief SummaryTo collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving A1501077 prescribes the voriconazole (VFEND).
ConditionScedosporium Infection
InterventionDrug: Voriconazole

Voriconazole Intravenous Solution 200 mg:

Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.

Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:

administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.

Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.

However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.

In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.

Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.

Other Name: VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet
Study Groups/CohortsVoriconazole
Subjects who are treated with voriconazole
Intervention: Drug: Voriconazole
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: August 6, 2012)
13
Original Actual EnrollmentSame as current
Actual Study Completion DateMay 2012
Actual Primary Completion DateMay 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on Scedosporisis.

Exclusion Criteria:

Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus, Candidasis,Cryptococcal infections not involving Scedosporisis.

Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01660334
Other Study ID NumbersA1501077
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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