NCT05178862终止3 期
A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 198
- 主要终点
- Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
研究概览
简要总结
This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis including candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
- •Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).
排除标准
- •Subject has any of the following forms of invasive candidiasis at Screening:
- •Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
- •Osteomyelitis,
- •Endocarditis or myocarditis,
- •Meningitis, endophthalmitis, or any central nervous system infection,
- •Chronic disseminated candidiasis,
- •Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
- •Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
- •Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
- •Patients who failed a previous antifungal therapy for the same infection,
- •Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
- •Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
- •Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).
- •Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.
- •o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
- •Baseline QTcF ≥ 500 msec.
研究组 & 干预措施
IV echinocandin followed by oral ibrexafungerp (SCY-078)
Experimental
干预措施: Echinocandin (Drug)
IV echinocandin followed by oral fluconazole
Active Comparator
干预措施: Echinocandin (Drug)
IV echinocandin followed by oral ibrexafungerp (SCY-078)
Experimental
干预措施: SCY-078 (Drug)
IV echinocandin followed by oral fluconazole
Active Comparator
干预措施: Fluconazole (Drug)
结局指标
主要结局
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
时间窗: Up to 6 weeks
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
All-cause mortality (US FDA Only)
时间窗: Day 30
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
All-cause Mortality
时间窗: Day 30
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
次要结局
- Global Response at Day 14(Day 14)
研究者
研究点 (198)
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