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Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

Last updated on November 11, 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.
Deep Mycosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-6
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or Female under age of seven patients who are prescribed fluconazole (Diflucan)
for antifungal treatment or prophylaxis administration.

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

- Subject of seven years or more who have been prescribed fluconazole.

NCT01680458
Pfizer
Completed
Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

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Descriptive Information
Brief TitleDiflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Official TitleSpecial Investigation Of Fluconazole For Pediatric Subjects
Brief SummaryTo collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).
ConditionDeep Mycosis
InterventionDrug: Fluconazole

Candidiasis infection: The recommended dosage in children is 3 mg/kg once daily.

Cryptococcal infection: The recommended dosage in children is 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy.

Prophylactic administration for deep mycosis on Hematopoietic stem cell transplantation: The recommended dosage in children is 12 mg/kg once daily.

Absolute doses exceeding 600 mg/day are not recommended.

Other Name: Diflucan
Study Groups/Cohortsfluconazole
Infant Subjects who are treated with fluconazole
Intervention: Drug: Fluconazole
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: July 1, 2015)
30
Original Estimated Enrollment
 (submitted: September 4, 2012)
60
Actual Study Completion DateOctober 2014
Actual Primary Completion DateOctober 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.

Exclusion Criteria:

  • Subject of seven years or more who have been prescribed fluconazole.
Sex/Gender
Sexes Eligible for Study:All
Agesup to 6 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01680458
Other Study ID NumbersA0561022
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 DateNovember 2015

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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