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

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NCT01660334

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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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Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)
Special Investigation of Vfend on Scedosporisis
To collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A1501077 prescribes the voriconazole (VFEND).
Scedosporium Infection
Drug: 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
Voriconazole
Subjects who are treated with voriconazole
Intervention: Drug: Voriconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01660334
A1501077
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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