Open-Label Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral Ibrexafungerp (SCY-078) as an Emergency Use Treatment for Patients With Candidiasis, Including Candidemia, Caused by Candida Auris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
研究概览
简要总结
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.
详细描述
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days.
Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment.
Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must fulfill the following KEY criteria to be eligible for study admission:
- •Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed.
- •Subject has a documented candidiasis, including candidemia, caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. A documented candidiasis, including candidemia, caused by Candida auris is defined as the recovery of Candida auris by culture of a sample obtained within the last 7 days.
- •Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.
排除标准
- •KEY exclusion criteria:
- •Subject has a fungal disease with central nervous system involvement.
- •Subject has a fungal disease of the bone and/or joint that is expected to require >90 days of study drug treatment.
- •Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
- •Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support.
- •Subject has abnormal liver test parameters: AST or ALT >10 x ULN, and/or total bilirubin >5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with diagnosis of Gilbert's disease are not excluded.
- •Subject has an Apache score >
- •Subject has serum creatinine >3 times from Baseline (Screening/Treatment Day 1) value.
研究组 & 干预措施
SCY-078
SCY-078
干预措施: SCY-078 (Drug)
结局指标
主要结局
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
时间窗: At (EoT) Visit (up to 90 days after Day 1)
The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.
次要结局
- Percentage of Participants With Recurrence of Baseline Fungal Infection(42 Days after the End of Treatment visit)
- Number of Participants Discontinued Due to Adverse Events(Through study completion (up to 132 Days))
- Percentage of Participants Surviving 42 and 84 Days(Day 42 and Day 84 after first dose of study drug)
- Percent of Participants With Treatment-emergent Adverse Events(Through study completion, up to 132 days)