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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01680458
First received: September 4, 2012
Last updated: August 21, 2014
Last verified: August 2014

September 4, 2012
August 21, 2014
November 2012
February 2015   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01680458 on ClinicalTrials.gov Archive Site
Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Special Investigation Of Diflucan For Infant 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.
 
Enrolling by invitation
60
February 2015
February 2015   (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.
Both
up to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01680458
A0561022
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP