Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

Completed

• Conditions: Deep Mycosis
• Interventions: Drug: Fluconazole

• Registration Number: NCT01680458
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-07
• Study Start: 2012-11
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-11-04
• Results First Submitted QC: 2015-11-04
• Results First Posted: 2015-12-09
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fluconazole	Fluconazole	Infant Subjects who are treated with fluconazole

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Serious Adverse Events	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	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 Adverse Events Unexpected From Japanese Package Insert	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

Name	Time	Method
Clinical Efficacy Rate	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.
Onset Rate of Deep Mycosis	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.
Fungi Eradication Rate	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