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

• ClinicalTrials.gov Identifier: NCT01680458
• Recruitment Status: Completed
• First Posted: September 7, 2012
• Results First Posted: December 9, 2015
• Last Update Posted: July 19, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Deep Mycosis	Drug: Fluconazole

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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

Groups and Cohorts

Group/Cohort

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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.).
2. 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.).
3. 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.).

Secondary Outcome Measures :

1. 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.
2. 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
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 0 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• 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

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. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01680458
• Other Study ID Numbers: A0561022
• First Posted: September 7, 2012
• Results First Posted: December 9, 2015
• Last Update Posted: July 19, 2021
• Last Verified: July 2021

Keywords provided by Pfizer:

antifungal treatment; prophylaxis; administration; Japanese; infants; fluconazole; Diflucan; Regulatory Post Marketing Commitment Plan.

Additional relevant MeSH terms:

Mycoses; Bacterial Infections and Mycoses; Infections; 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