An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
- Conditions
- -B37 CandidiasisCandidiasisB37
- Registration Number
- PER-002-99-B
- Lead Sponsor
- FUJISAWA HEALTH CARE INC,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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).<br>Measure:Successful treatment at the end of therapy<br>Timepoints:at the end of therapy<br>
- Secondary Outcome Measures
Name Time Method