None listed
Conditions
Interventions
FK463 Type of group
FK463 will be administered daily as an intravenous infusion of one hour. The maximum time a patient can receive FK463 is 90 days. Patients with therapeutic failure can receive FK463 alone or receive FK463 added to their current antifungal regimen.
Sponsors
FUJISAWA HEALTH CARE INC,
Eligibility
Inclusion criteria
Inclusion criteria: a. Prior to inclusion, an informed consent of the patient or legally authorized representative must be obtained. Get a informed assent from underage patients able to understand. b. Patients can be of any sex. Female patients of childbearing age must have a negative pregnancy test. c. Patients must have a proven or probable systemic infection caused by Aspergillus species (see Appendix A for diagnostic criteria). d. Patients should have adequate venous access to allow administration of FK463 and monitoring of safety variables.
Exclusion criteria
Exclusion criteria: a. Patients who are pregnant or breast-feeding. Women of childbearing age should avoid pregnancy while receiving treatment with the study drug. b. Patients with any of the following abnormal liver test parameters: 1. AST or ALT> 10 times over the normal limit (ULN) 2. Total bilirubin> 5 times ULN 3. Alkaline Phosphatase> 5 times ULN c. Patients with allergic bronchopulmonary aspergillosis, aspergillomas, paranasal aspergillosis or otitis externa that have no histopathological evidence of tissue invasion. d. Patients with a life expectancy considered to be less than 5 days. e. Patients with a history of allergies, hypersensitivity or any serious reaction to the echinocandin class of antifungals f. Patients who have participated in this study previously. g. Patients with a concomitant medical condition, in the opinion of the investigator and / or clinical monitor, whose participation may create an additional unacceptable risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Specified clinical criteria Measure:Anti fungal efficacy evaluation: Clinical response Timepoints:Day 14, day 28 and end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:blood cultures Measure:Relapse during the post-treatment phase Timepoints:Finished the treatment | — |
Outcome results
None listed