Short-Course Antifungal Therapy vs Standard of Care (14 Day Therapy) for Uncomplicated Candidemia (SCAT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Eradication of candida from the blood at day 7 or day 14
研究概览
简要总结
The goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients ≥ 18 years of age
- •Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day
- •Received < 5 days of prior antifungal therapy
- •Informed Consent for randomization
- •Patients that did not consent to randomization have consented to be used as a natural history (controls) and will allow collection of available data from the medical record.
排除标准
- •Inadequate source control (e.g., unable to remove endovascular devices, urinary catheters).
- •Invasive candidiasis of any type (e.g., deep seated candidiasis from sources other than blood)
- •Abnormal LFTs > 10-fold
- •Greater than 5 days of prior antifungal therapy
- •Endovascular devices that cannot be removed.
- •Immunocompromised patients (AIDS/HIV; solid organ transplant, bone marrow transplant patients, oncology patients receiving chemotherapy, neutropenic patients (ANC of < 1,500 cells/L
- •Neutropenic at time of consent (what does this mean)
- •Break-through candidemia (people with prior candidemia who relapsed) after treatment with antifungal therapy)
- •Unable to provide informed consent from either the patient or legally authorized authority (LAR)
- •Expected mortality within 96 hours
研究组 & 干预措施
7 Days
Study participants randomized to the 7 Day group will receive the short-course antifungal therapy for 7 days.
干预措施: Antifungal treatment (Drug)
14 Days
Study participants randomized to the 14 Day group will receive the standard of care antifungal therapy for 14 days.
干预措施: Antifungal treatment (Drug)
结局指标
主要结局
Eradication of candida from the blood at day 7 or day 14
时间窗: 14 Days
Blood culture monitoring at day 7 and day 14
次要结局
未报告次要终点
研究者
Jose Vazquez
Principal Investigator
Augusta University