EUCTR2017-003571-56-ES进行中（未招募）1 期
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non-Neutropenic Patients with Candidemia, with or without Invasive Candidiasis, Inclusive of Patients with Suspected Resistance to Standard of Care Antifungal Treatment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female 18 to 80 years of age (inclusive)
- •2. New diagnosis of candidemia based on a blood sample drawn within 96 hours of dosing with:
- •a. Positive blood culture for Candida spp., including those Candida spp. with suspected (in the opinion of the Investigator) or documented resistance to at least 1 SOC systemic antifungal agent
- •b. Positive result from a Sponsor-approved rapid diagnostic blood test for Candida spp. infection (a rapid diagnostic test may be used to begin eligibility assessments; however, a subsequent confirmatory blood culture is required prior to dosing of APX001)
- •3. Able to have pre-existing intravascular catheters removed and replaced (if necessary)
- •4. Females of childbearing potential must have a negative urine pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Neutropenia defined as absolute neutrophil count <500 cells/µL
- •2. Diagnosis of deep-seated Candida-related infections causing intraperitoneal Candidiasis, septic arthritis, osteomyelitis, endocarditis, myocarditis, meningitis, or central nervous system infection or site of infection that would require antifungal treatment to exceed maximal duration of study drug (14 days)
- •3. Hepatosplenic Candidiasis
- •4. Blood culture, or any other culture, positive for C. krusei
- •5. Received >2 days (>48 hours) equivalent of prior systemic antifungal treatment at approved doses to treat the current episode of candidemia (e.g., 2 consecutive doses of an echinocandin)
- •Note: = 5 days (=120 hours) equivalent of prior antifungal treatment is permitted for patients with candidemia caused by Candida spp. with documented resistance to the specific prior antifungal administered.
研究者
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