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

September 4, 2012
November 4, 2015
November 2012
October 2014   (final data collection date for primary outcome measure)
  • 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.).
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01680458 on ClinicalTrials.gov Archive Site
  • 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.
Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Special Investigation Of Fluconazole For Pediatric 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.
 
Completed
30
October 2014
October 2014   (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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01680458
A0561022
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2015

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