Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

NCT01680458

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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.

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Advanced Information
Descriptive Information
Brief Title Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Official Title Special Investigation Of Fluconazole For Pediatric Subjects
Brief Summary To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).
Condition Deep Mycosis
Intervention 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
Study Groups/Cohorts fluconazole
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 Status Completed
Actual Enrollment
 (submitted: July 1, 2015)
30
Original Estimated Enrollment
 (submitted: September 4, 2012)
60
Actual Study Completion Date October 2014
Actual Primary Completion Date October 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
Ages up to 6 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01680458
Other Study ID Numbers A0561022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2015