2024-511755-18-00暂停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)
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 72
- 试验地点
- 34
- 主要终点
- All-cause Mortality (ACM) at Day 30 in the ITT population. The percentage of subjects with Successful Global Response, as determined by the DRC at EOT (European Union [EU] only).
研究概览
简要总结
To demonstrate that treatment of Invasive Candidiasis/Candidemia with intravenous (IV) echinocandin followed by oral ibrexafungerp is non-inferior to IV echinocandin followed by oral fluconazole (or Best Available Therapy [or BAT]).
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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/fluid culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ± 4 days (96 hours) of initiation of IV echinocandin accompanied by any related clinical sign and/or symptom (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation, etc.).
排除标准
- •Subject has any of the following forms of invasive candidiasis at Screening: a. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed), b. Osteomyelitis, c. Endocarditis or myocarditis, d. Meningitis, endophthalmitis, or any central nervous system infection, e. Chronic disseminated candidiasis, f. Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract, g. 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, h. Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection, i. Patients who failed a previous antifungal therapy for the same infection, j. Subject has an uncontrolled 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 due to 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. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
- •Baseline QTcF ≥ 500 msec, history or family history of Torsades de Pointes or other conditions that would put the subject at undue risk for development of ventricular arrythmias (including Torsades de Pointes).
结局指标
主要结局
All-cause Mortality (ACM) at Day 30 in the ITT population. The percentage of subjects with Successful Global Response, as determined by the DRC at EOT (European Union [EU] only).
All-cause Mortality (ACM) at Day 30 in the ITT population. The percentage of subjects with Successful Global Response, as determined by the DRC at EOT (European Union [EU] only).
次要结局
- Key secondary endpoint: The percentage of subjects with Successful Global Response, as determined by the DRC (based on clinical response as determined by the PI, mycological response and radiological response [when applicable]) at Day 14.
- Efficacy Endpoints: The percentage of subjects with Successful Global Response at Day 30 and EOT as determined by the PI and the DRC.
- Efficacy Endpoints: The percentage of subjects with Successful Clinical Response at Day 14, Day 30 and EOT as determined by the PI and the DRC.
- Efficacy Endpoints: The percentage of subjects with Successful Mycological Response at Day 14, Day 30 and EOT as determined by the DRC.
- Efficacy Endpoints: The percentage of subjects with no recurrence at 2 weeks and 6 weeks after EOT as determined by the DRC.
- Efficacy Endpoints: The percentage of subjects alive with Successful Global Response at EOT and no recurrence at 6 weeks after EOT as determined by the DRC.
- Safety Endpoints: Frequency of treatment-emergent adverse events (TEAEs), drug-related adverse events, discontinuations due to AEs, serious adverse events (SAEs), and safety laboratory assessments.
- PK Endpoint: Description of ibrexafungerp plasma concentrations.
研究者
David Angulo
Scientific
Scynexis Inc.
研究点 (34)
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