Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 30
- 主要终点
- Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
研究概览
简要总结
The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.
详细描述
Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
- •Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.
排除标准
- •Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
- •Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
- •Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
- •Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.
研究组 & 干预措施
SCY-078 500 mg
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
干预措施: SCY-078 (Drug)
SCY-078 750 mg
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
干预措施: SCY-078 (Drug)
Standard-of-care
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
干预措施: Fluconazole (Drug)
Standard-of-care
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
干预措施: Micafungin (Drug)
结局指标
主要结局
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
时间窗: up to 10 weeks
All Related TEAEs by SOC and PT, by Treatment, Safety
Dose of SCY-078 That Achieves the Target Exposure (AUC)
时间窗: 0 to 24 hours post-dose
Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
次要结局
- Global Response(end of all antifungal therapy (administered for a maximum of 28 days))
- Clinical Response(end of all antifungal therapy (administered for a maximum of 28 days))
- Microbiological Response(end of all antifungal therapy (administered for a maximum of 28 days))
- Relapse(2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks)