A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 793
- 试验地点
- 50
- 主要终点
- Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.
研究概览
简要总结
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
详细描述
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) safety via assessment of treatment-emergent adverse events and (ii) efficacy of RBX2660 preventing recurrent episodes of CDI measured at 8 weeks after treatment. Follow-up office visits occur at 1 week and 8 weeks after completing the initial study treatment. Telephone assessments occur at 4 weeks, and 4 and 6 months after the study. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
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
- •≥ 18 years old.
- •Medical record documentation of either: a) a current diagnosis or history of recurrent CDI as determined by the treating physician, b) or has had at least two episodes of severe CDI resulting in hospitalization.
- •Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. [Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking antibiotics during screening.]
排除标准
- •Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
- •Requires systemic antibiotic therapy for a condition other than CDI.
- •Fecal microbiota transplant (FMT) within the past 6 months.
- •FMT with an associated serious adverse event related to the FMT product or procedure.
- •Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
- •CD4 count <200/mm^3 during Screening.
- •An absolute neutrophil count of <1000 cells/µL during Screening.
- •Pregnant, breastfeeding, or intends to become pregnant during study participation.
研究组 & 干预措施
Active
RBX2660 is an enema of a microbiota suspension
干预措施: RBX2660 (Drug)
结局指标
主要结局
Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.
时间窗: Up to 6 months after last study treatment.
Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
次要结局
- Sustained Clinical Response Through 6 Months After Treatment.(6 months after completing the study treatment)
- Efficacy of RBX2660 Measured at 8 Weeks After Treatment.(8 weeks after completing the study treatment)