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Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

Last updated on May 9, 2018

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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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Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Special Investigation Of Fluconazole For Pediatric Subjects
To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).
Deep Mycosis
Drug: 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
fluconazole
Infant Subjects who are treated with fluconazole
Intervention: Drug: Fluconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2014
October 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01680458
A0561022
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2015

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