Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication (DREAM)
To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Special Investigation Of Fluconazole For Pediatric Subjects|
- Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Study Completion Date:||October 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Infant Subjects who are treated with 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680458
|Study Director:||Pfizer CT.gov Call Center||Pfizer|