Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication (DREAM)
|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|