Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01680458
First received: September 4, 2012
Last updated: November 4, 2015
Last verified: November 2015
  Purpose
To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.

Condition Intervention
Deep Mycosis
Drug: Fluconazole

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: MAX 13 Weeks ] [ Designated as safety issue: Yes ]
    A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  • Number of Participants With Treatment-Related Serious Adverse Events [ Time Frame: MAX 13 Weeks ] [ Designated as safety issue: Yes ]
    A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  • Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: MAX 13 Weeks ] [ Designated as safety issue: Yes ]
    A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).


Secondary Outcome Measures:
  • Clinical Efficacy Rate [ Time Frame: MAX 13 Weeks ] [ Designated as safety issue: No ]
    Clinical effect of treatment was evaluated based on the clinical course excluding mycological effect as follows: (1) effective, (2) ineffective, or (3) unevaluable. Clinical efficacy rate was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Clinical efficacy rate (%) = (Number of responders in evaluation of clinical effect) / (Number of participants available for clinical efficacy evaluation) x 100.

  • Fungi Eradication Rate [ Time Frame: MAX 13 Weeks ] [ Designated as safety issue: No ]
    Mycological effect of treatment was evaluated as follows: (1) eradicated; the causative fungi detected from the lesion before treatment became undetectable, (2) presumably eradicated; the lesion was improved and sampling of causative fungi became impossible, (3) decreased; the causative fungi were decreased, (4) unchanged; no change was observed in the causative fungi, (5) increased; the causative fungi were increased (including microbial substitution), and (6) indeterminate; the clinical follow-up was inadequate, causative fungi were undetectable, or mycological test was not performed. Fungi eradication rate was calculated as follows. Fungi eradication rate (%) = (Number of participants evaluated as "eradicated" or "presumably eradicated") / (Number of participants available for mycological efficacy evaluation) x 100

  • Onset Rate of Deep Mycosis [ Time Frame: MAX 13 Weeks ] [ Designated as safety issue: No ]
    Efficacy of deep mycosis prophylaxis was evaluated by the presence or absence of deep mycosis onset during the observation period. Onset rate of deep mycosis was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Onset rate of deep mycosis (%) = (Number of participants with deep mycosis onset by target fungi) / (Number of participants available for prophylactic efficacy evaluation) x 100.


Enrollment: 30
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01680458     History of Changes
Other Study ID Numbers: A0561022 
Study First Received: September 4, 2012
Results First Received: November 4, 2015
Last Updated: November 4, 2015
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
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors

ClinicalTrials.gov processed this record on December 06, 2016