Serious Fungal Infections
Conditions
Keywords
voriconazole, Korea, invasive fungal infection
Brief summary
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
Interventions
DRUGvoriconazole IV
6 mg/kg iv q 12 hours (loading) then maintenance
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Invasive aspergillosis and other serious fungal infections.
Exclusion criteria
* N/A
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 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 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 medication; Not evaluable=a follow-up mycological cultivation is not performed. |
Participant flow
Pre-assignment details
There were 692 participants enrolled in this study. Of these, 379 participants were treated with the IV formulation of Vfend only, and 313 participants were treated with Vfend IV and Vfend tablets sequentially or vice versa. These 313 participants are also included in study A1501068 (NCT01073631).
Participants by arm
| Arm | Count |
|---|---|
| Vfend Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD. | 692 |
| Total | 692 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 19 |
| Overall Study | Death | 208 |
| Overall Study | Other | 80 |
Baseline characteristics
| Characteristic | Vfend |
|---|---|
| Age, Customized <18 years | 97 participants |
| Age, Customized >=65 years | 95 participants |
| Age, Customized Between 18 and 44 years | 218 participants |
| Age, Customized Between 45 and 64 years | 282 participants |
| Sex: Female, Male Female | 275 Participants |
| Sex: Female, Male Male | 417 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 94 / 692 |
| serious Total, serious adverse events | 239 / 692 |
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 years
Population: Safety population: participants received at least 1 dose of study drug for the 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 parameters at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vfend | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Cure | 12.72 percentage of participants |
| Vfend | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Improvement | 41.47 percentage of participants |
| Vfend | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Failure | 17.92 percentage of participants |
| Vfend | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Unevaluable | 27.89 percentage of participants |
Comparison: Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement95% CI: [71.36, 78.94]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 medication; Not evaluable=a follow-up mycological cultivation is not performed.
Time frame: Baseline (Day 1) up to 2 years
Population: ITT; N=number of subjects 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 | 64.78 percentage of participants |
| Vfend | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | Persistence | 27.67 percentage of participants |
| Vfend | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | Superinfection | 3.77 percentage of participants |
| Vfend | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | Not evaluable | 3.77 percentage of participants |