Mycoses
Conditions
Brief summary
The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.
Detailed description
Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs & symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome will be collected on abstracted electronic Case Report Forms. This surveillance study was originally limited to subjects receiving posaconazole as salvage antifungal therapy as indicated. A subgroup of subjects at risk for invasive fungal infection was included for prophylactic treatment following the enlargement of the marketing authorization for NOXAFIL® (posaconazole) during the course of the study. These participants only contributed data for the assessment of safety.
Interventions
DRUGPosaconazole
The usual dose of NOXAFIL® is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL® is administered at a dose of 200 mg (5 mL) four times daily.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult subjects with: * Invasive aspergillosis refractory to, or intolerant of, amphotericin B or itraconazole, * Fusariosis refractory to, or intolerant of, amphotericin B, * Chromoblastomycosis and mycetoma refractory to, or intolerant of, itraconazole, * Coccidiomycosis refractory to, or intolerant of, amphotericin B, itraconazole or fluconazole. * Subjects receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk for developing invasive fungal infections. * Hematopoietic stem-cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for Graft-versus-host disease and who are at high risk for developing invasive fungal infections.
Exclusion criteria
* Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Adverse Drug Reactions. | Before starting treatment with posaconazole, during treatment, and until 100 days after treatment. | The severity of an Adverse Drug Reaction is determined on the basis of the following definitions: Mild: The abnormality, symptom or event is noticed but well tolerated. Moderate: Symptoms impair normal activities and may require intervention. Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Posaconazole (Assigned by Physician in Normal Practice) * Treatment of invasive fungal infection.
* Prophylaxis of invasive fungal infection. | 214 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lack of Efficacy | 25 |
| Overall Study | Missing | 42 |
| Overall Study | Other | 16 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Posaconazole (Assigned by Physician in Normal Practice) |
|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 12.77 |
| Region of Enrollment Germany | 214 participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 214 |
| serious Total, serious adverse events | 33 / 214 |
Outcome results
Primary
Number of Participants Reporting Adverse Drug Reactions.
The severity of an Adverse Drug Reaction is determined on the basis of the following definitions: Mild: The abnormality, symptom or event is noticed but well tolerated. Moderate: Symptoms impair normal activities and may require intervention. Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required.
Time frame: Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Posaconazole (Assigned by Physician in Normal Practice) | Number of Participants Reporting Adverse Drug Reactions. | All | 52 Participants |
| Posaconazole (Assigned by Physician in Normal Practice) | Number of Participants Reporting Adverse Drug Reactions. | Mild | 30 Participants |
| Posaconazole (Assigned by Physician in Normal Practice) | Number of Participants Reporting Adverse Drug Reactions. | Moderate | 21 Participants |
| Posaconazole (Assigned by Physician in Normal Practice) | Number of Participants Reporting Adverse Drug Reactions. | Severe | 1 Participants |