Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 270
- 主要终点
- Survival
研究概览
简要总结
This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).
详细描述
Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CSF cryptococcal antigen (CrAg) positive meningitis
- •Ability and willingness to provide informed consent
- •Willing to receive protocol-specified lumbar punctures
排除标准
- •Glasgow Coma Scale < 15 at time of consent
- •Received >= 3 doses of amphotericin B within prior 30 days
- •Inability to take enteral (oral or nasogastric) medicine
- •Cannot or unlikely to attend regular clinic visits
- •Receiving chemotherapy or corticosteroids
- •Suspected paradoxical immune reconstitution inflammatory syndrome (IRIS)
- •Pregnancy or breastfeeding
- •Previous administration of MAT2203
- •Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments
研究组 & 干预措施
MAT2203 Induction / MAT2203 Consolidation
2 days IV Amphotericin B (AMB) + flucytosine (5FC) followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by MAT2203 +fluconazole for 4 weeks of consolidation therapy
干预措施: MAT2203 (Drug)
MAT2203 Induction / SOC Consolidation
2 days IV AMB + 5FC followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by 4 weeks of standard of care consolidation therapy
干预措施: MAT2203 (Drug)
SOC Induction / SOC Consolidation
Standard of care induction therapy (IV AMB + 5FC) followed by 4 weeks of standard of care consolidation therapy (fluconazole)
干预措施: Amphotericin B (Drug)
结局指标
主要结局
Survival
时间窗: 2 weeks
All-cause mortality
次要结局
- Meningitis-free survival(10 weeks)
- Evidence of fungicidal activity(2 weeks)
- CSF culture sterility(10 weeks)