Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication (DREAM)
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|ClinicalTrials.gov Identifier: NCT01680458|
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : December 9, 2015
Last Update Posted : July 19, 2021
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|Condition or disease||Intervention/treatment|
|Deep Mycosis||Drug: Fluconazole|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Special Investigation Of Fluconazole For Pediatric Subjects|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Infant Subjects who are treated with 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
- Number of Participants With Treatment-Related Adverse Events [ Time Frame: MAX 13 Weeks ]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 ]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 ]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.).
- Clinical Efficacy Rate [ Time Frame: MAX 13 Weeks ]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 ]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 ]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.
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|Ages Eligible for Study:||0 Years to 6 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.
- Subject of seven years or more who have been prescribed fluconazole.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680458
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|First Posted:||September 7, 2012 Key Record Dates|
|Results First Posted:||December 9, 2015|
|Last Update Posted:||July 19, 2021|
|Last Verified:||July 2021|
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