Serious Fungal Infections
Conditions
Keywords
voriconazole, Korea, invasive fungal infection
Brief summary
This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.
Interventions
DRUGvoriconazole tablet
200 mg PO bid (orally, twice a day)
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are indicated for voriconazole table according to the drug package insert.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Baseline (Day 1) up to 2.1 Years | Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | Baseline (Day 1) up to 2.1 Years | In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed. |
Participant flow
Pre-assignment details
There were 543 participants enrolled in this study. Of these, 230 participants were treated with the Vfend tablet formulation only, and 313 participants were treated with Vfend tablet and Vfend intravenous (IV) formulations sequentially or vice versa. These 313 participants are also included in Study A1501067 (NCT01073618).
Participants by arm
| Arm | Count |
|---|---|
| Vfend Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours \[loading dose\], 3 to 4mg/kg IV infusion every 12hours \[maintenance dose\]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity. | 543 |
| Total | 543 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 24 |
| Overall Study | Death | 82 |
| Overall Study | Other | 63 |
Baseline characteristics
| Characteristic | Vfend |
|---|---|
| Age, Customized <18 years | 74 Participants |
| Age, Customized >=65 years | 105 Participants |
| Age, Customized Between 18 and 44 years | 157 Participants |
| Age, Customized Between 45 and 64 years | 207 Participants |
| Sex: Female, Male Female | 211 Participants |
| Sex: Female, Male Male | 332 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 154 / 543 |
| serious Total, serious adverse events | 119 / 543 |
Outcome results
Primary
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable
Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).
Time frame: Baseline (Day 1) up to 2.1 Years
Population: Safety population: participants received at least 1 dose of study drug for approved indication (= Intent to treat \[ITT\] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related paramenters at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vfend | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Cure | 36.83 Percentage of participants |
| Vfend | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Improvement | 26.52 Percentage of participants |
| Vfend | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Failure | 16.94 Percentage of participants |
| Vfend | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Unevaluable | 19.71 Percentage of participants |
Comparison: Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement95% CI: [75.07, 82.73]Normal approximation to binomial
Secondary
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable
In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.
Time frame: Baseline (Day 1) up to 2.1 Years
Population: ITT; N=number of participants evaluated for mycological response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vfend | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | Eradication | 71.59 Percentage of participants |
| Vfend | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | Persistence | 23.86 Percentage of participants |
| Vfend | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | Superinfection | 2.27 Percentage of participants |
| Vfend | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | Not evaluable | 2.27 Percentage of participants |