Scedosporium Infection
Conditions
Keywords
Systemic Mycosis, Scedosporium infection, Scedosporisis, Japanese, voriconazole, VFEND, Regulatory Post Marketing Commitment Plan.
Brief summary
To collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.
Interventions
DRUGVoriconazole
Voriconazole Intravenous Solution 200 mg: Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults. Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg: administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward. Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased. However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily. In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward. Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on Scedosporisis.
Exclusion criteria
Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus, Candidasis,Cryptococcal infections not involving Scedosporisis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Treatment Related Adverse Events. | 16 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit. | 16 weeks | The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis. Clinical response of cure was assessed comprehensively by physicians in the three categories, which were effective, ineffective, and not evaluable, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Voriconazole for Scedosporium Disease Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Voriconazole for Scedosporium Disease |
|---|---|
| Age, Customized <65 years | 4 participants |
| Age, Customized >=65 years | 8 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 12 |
| serious Total, serious adverse events | 2 / 12 |
Outcome results
Primary
Number of Participants With Serious Treatment Related Adverse Events.
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
Time frame: 16 weeks
Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole for Scedosporium Disease | Number of Participants With Serious Treatment Related Adverse Events. | 2 participants |
Secondary
Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.
The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis. Clinical response of cure was assessed comprehensively by physicians in the three categories, which were effective, ineffective, and not evaluable, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests.
Time frame: 16 weeks
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole for Scedosporium Disease | Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit. | 6 participants |