A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (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
- 206
- 试验地点
- 54
- 主要终点
- Number of Participants With Occurrence of Treatment Emergent Adverse Events
研究概览
简要总结
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile.
Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.
详细描述
This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection (CDI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men or women 18 years of age or older
- •Current diagnosis of a recurrence of non-severe, non-complicated CDI
- •Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode
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
- •History of total colectomy/ileostomy or bariatric surgery
- •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
- •Planned hospitalization or invasive surgery during the study
- •Severe acute illness unrelated to CDI
研究组 & 干预措施
CP101
Full Spectrum Microbiota Capsule
干预措施: Full Spectrum Microbiota (Drug)
Placebo
Matching Placebo Capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Occurrence of Treatment Emergent Adverse Events
时间窗: Week 8
Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
时间窗: Week 8
Defined in the protocol as sustained clinical cure
次要结局
- Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication(Week 24)
- Time to First Recurrent CDI Episode During the Study(Week 8)
- Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype(Up to Week 8)