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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: May 1, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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: May 1, 2013
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 May 23, 2013