Deep Mycosis
Conditions
Keywords
antifungal treatment, prophylaxis, administration, Japanese, infants, fluconazole, Diflucan, Regulatory Post Marketing Commitment Plan.
Brief summary
To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.
Interventions
DRUGFluconazole
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.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluconazole Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 3 |
Baseline characteristics
| Characteristic | Fluconazole |
|---|---|
| Age, Customized 1 to less than 7 years | 22 Participants |
| Age, Customized 4 weeks to less than 1 year | 4 Participants |
| Age, Customized Less than 4 weeks | 1 Participants |
| Reason for administration, Treatment/Prophylaxis Prophylaxis | 25 Participants |
| Reason for administration, Treatment/Prophylaxis Treatment | 2 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 27 |
| serious Total, serious adverse events | 2 / 27 |
Outcome results
Primary
Number of Participants With Treatment-Related Adverse Events
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.).
Time frame: MAX 13 Weeks
Population: SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluconazole | Number of Participants With Treatment-Related Adverse Events | 1 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
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.).
Time frame: MAX 13 Weeks
Population: SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluconazole | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 0 Participants |
Primary
Number of Participants With Treatment-Related Serious Adverse Events
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.).
Time frame: MAX 13 Weeks
Population: SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluconazole | Number of Participants With Treatment-Related Serious Adverse Events | 0 Participants |
Secondary
Clinical Efficacy Rate
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.
Time frame: MAX 13 Weeks
Population: Efficacy analysis set for treatment comprised of participants in safety analysis set (SAS) who had started to receive fluconazole for the treatment and had been evaluated for the clinical effect.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluconazole | Clinical Efficacy Rate | 100 Percentage of participants |
Secondary
Fungi Eradication Rate
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
Time frame: MAX 13 Weeks
Population: Mycological analysis set for treatment comprised of participants in SAS with the final diagnosis of deep mycosis, who had started to receive fluconazole for the treatment and had been evaluated for the mycological effect.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluconazole | Fungi Eradication Rate | 0 Percentage of participants |
Secondary
Onset Rate of Deep Mycosis
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.
Time frame: MAX 13 Weeks
Population: Efficacy analysis set for prophylaxis comprised of participants in SAS who had started to receive fluconazole for the prophylaxis and had been evaluated for the presence or absence of deep mycosis onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluconazole | Onset Rate of Deep Mycosis | 0 Percentage of participants |