None listed
Conditions
Interventions
The initial dose of FK463 will be 50 mg / day (1.0 mg / kg / day for pediatric patients weighing # 40 kg). administered as an hourly intravenous infusion. FK463 will be administered for a minimum of 5 days and for a maximum of up to 6 weeks, based on the patients clinical response.
Sponsors
FUJISAWA HEALTH CARE INC,
Eligibility
Inclusion criteria
Inclusion criteria: • Prior to inclusion, informed consent must be obtained from the patient or the legally authorized representative. An agreement will be obtained from the underage patients able to understand. • Patients can be of any sex. Female patients of childbearing age must have a negative pregnancy test. • Patients must have documented candidemia or invasive candidiasis demonstrated by clinical signs and symptoms and confirmed by fungal culture or histological confirmation as specified in Appendix A of the protocol. • Patients must have adequate venous access to allow the administration of FK463 and the monitoring of safety variables.
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding patients. Women of childbearing age should avoid pregnancy while receiving treatment with the drug being studied. • Patients with any of the following abnormal liver test parameters: 1. AS r or ALT> 10 times above the normal (ULN) limit 2. Total bilirubin> 5 times ULN 3. Alkaline phosphatase> 5 times ULN. • Patients with a life expectancy considered less than 5 days. • Patients with a history of allergies, hypersensitivity or any serious reaction to antifungals of the echinocandin class. • De novo patients who have received a systemic antifungal agent for the treatment of this episode of invasive candidemia or candidiasis, for more than 48 hours prior to the first dose of FK463; or patients with therapeutic failure who have received U 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis. • Patients who require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis. • Patients who have participated in this study before. • Patients with a concomitant medical condition, which in the opinion of the investigator and / or clinical monitor, participation may create an additional risk unacceptable to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The success of the treatment is defined as a complete or partial clinical response. A confidence interval (95% bilateral) for the main final objective will be presented together with a summary of the incidence of treatment success. The success of the treatment will be summarized for all patients and by group of patients (de novo and with therapeutic failure). Measure:Successful treatment at the end of therapy Timepoints:at the end of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical response assessments will be based on the following definitions: Complete answer: Resolution of all the signs and symptoms and attributable radiographic abnormalities, if present at baseline. Partial response: Improvement in signs and symptoms, and in radiographic abnormalities, if they were present at baseline. Stabilization: Mild improvement or no change in signs and symptoms, attributable radiographic abnormalities, if they were present at baseline, and the patient continues in therapy without deterioration of their condition. Progression: Deterioration in signs and symptoms, in attributable radiographic abnormalities, if they were present at baseline; or alternative antifungal therapy is required; or death occurs. Measure:Incidence of clinical response Timepoints:weekly and at the end of therapy ; Outcome name:Persistence: Continuous isolation or histological documentation of the primary site. Eradication: Absence documented by culture or histologically of the infectious species of Candida from the primary site and from previously positive surveillance sites. Eradication can be assumed when a patient has a complete response and repeat culture / biopsy is contraindicated. Measure:Incidence of mycological response (persistence and eradication) to FK463 on Day 14 and at the end of therapy Timepoints:Day 14 and at the end of therapy | — |
Outcome results
None listed