PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 110
- 主要终点
- Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
研究概览
简要总结
This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101.
Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.
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
- •Ability to provide written informed consent;
- •Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit; OR recurrent CDI
- •An outpatient prior to Treatment
- •Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period.
排除标准
- •Pregnant, breast-feeding, or considering becoming pregnant during the study
- •Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
- •Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
- •Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
- •Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
- •Major intra-abdominal surgery within the past 60 days prior to Screening
- •Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
- •History of total colectomy/ileostomy or bariatric surgery
- •Planned hospitalization or invasive surgery during the study
- •Severe acute illness unrelated to CDI
结局指标
主要结局
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
时间窗: Up to Week 8
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Occurence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Week 8
次要结局
- Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication(Up to Week 24)