An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 29
- 主要终点
- Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC)
研究概览
简要总结
This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and older.
Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks.
This study will be conducted at approximately 20 sites in the United States and globally.
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
- •Provision of written consent
- •Adults ages 18 and above male or female
- •New diagnosis of candidemia
- •Able to have pre-existing intravascular catheters removed and replaced (as necessary)
排除标准
- •neutropenia
- •deep-seated Candida-related infections
- •hepatosplenic candidiasis
- •received more than 2 days of prior systemic antifungal treatment for current candidemia episode
- •severe hepatic impairment
研究组 & 干预措施
APX001 Treatment
干预措施: APX001 (Drug)
结局指标
主要结局
Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC)
时间窗: One to forty-two days
Treatment Success is defined as meeting all of the following criteria: Two consecutive blood cultures negative for Candida spp. Alive at EOST No concomitant use of any other systemic antifungal therapies through end of study treatment
次要结局
- Time to First Negative Blood Culture(One to forty-nine days)
- Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)(End of study treatment (EOST), end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT))
- Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)(2 and 4 weeks after end of treatment (EOT))
- Overall Survival at Study Day 30(Day 30)
- Number of Patients With Treatment Emergent Adverse Events (TEAEs)(One to forty-nine days)