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: April 16, 2014
Last verified: April 2014
  Purpose

To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.


Condition Intervention Phase
Deep Mycosis
Drug: Fluconazole
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation Of Diflucan For Infant Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fluconazole
Infant Subjects who are treated with fluconazole
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

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680458

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01680458     History of Changes
Other Study ID Numbers: A0561022
Study First Received: September 4, 2012
Last Updated: April 16, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
antifungal treatment
prophylaxis
administration
Japanese
infants
fluconazole
Diflucan
Regulatory Post Marketing Commitment Plan.

Additional relevant MeSH terms:
Mycoses
Antifungal Agents
Fluconazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014