Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)
2020年12月23日 更新者：Rebiotix Inc.
A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes.
Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds 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.
Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
研究概览
详细说明
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes.
The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events.
Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment.
Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds 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.
Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
研究类型
介入性
注册 (实际的)
150
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z 1M9
- University of British Columbia
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Ontario
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Hamilton、Ontario、加拿大、L8N 4A6
- St. Joseph's Hospital
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Arizona
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Phoenix、Arizona、美国、85054
- Mayo Clinic Arizona
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado
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Florida
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Jacksonville、Florida、美国、32256
- Borland-Groover Clinic
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Idaho
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Idaho Falls、Idaho、美国、83404
- Grand Teton Research Group
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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Chicago、Illinois、美国、60153
- Loyola University Chicago
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Indiana
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Indianapolis、Indiana、美国、46260
- Infectious Diseases of Indiana
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Maryland
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Chevy Chase、Maryland、美国、20815
- Chevy Chase Clinical Research
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Health System
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic Minnesota
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Saint Paul、Minnesota、美国、55101
- Regions Hospital
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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New York
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Flushing、New York、美国、11355
- New York Hospital Queens
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New York、New York、美国、10065
- New York-Presbyterian Hospital/Weill Cornell Medical College
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Rochester、New York、美国、14618
- Gastroenterology Group of Rochester
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North Dakota
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Fargo、North Dakota、美国、58122
- Sanford Health
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Ohio
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Cleveland、Ohio、美国、44106
- Louis Stokes Cleveland VA Medical Center
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Lima、Ohio、美国、45801
- Regional Infectious Diseases and Infusion Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- ≥ 18 years
- Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
- Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
- A positive stool test for the presence of C. difficile within 60 days prior to enrollment.
Exclusion Criteria:
- A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
- Requires antibiotic therapy for a condition other than recurrent CDI.
- Previous fecal transplant prior to study enrollment.
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- History of irritable bowel syndrome (IBS).
- History of chronic diarrhea.
- History of celiac disease.
- Colostomy.
- Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
- Life expectancy of < 12 months.
- Compromised immune system.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Group A
Two enemas of RBX2660 (microbiota suspension) administered 7 days apart
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A suspension of intestinal microbes
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安慰剂比较：Group B
Two enemas of placebo administered 7 days apart
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A suspension of saline and cryoprotectant
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有源比较器：Group C
1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart
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A suspension of intestinal microbes
A suspension of saline and cryoprotectant
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT)
大体时间：8 weeks after last assigned study treatment
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The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).
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8 weeks after last assigned study treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT)
大体时间：8-weeks
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Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema
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8-weeks
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Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT)
大体时间：8-weeks
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Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema.
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8-weeks
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SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT)
大体时间：8-week
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The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment.
Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL.
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8-week
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Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT)
大体时间：8-weeks
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Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
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8-weeks
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Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT)
大体时间：8-weeks
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Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
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8-weeks
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Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT)
大体时间：8-weeks
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Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
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8-weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Teena Chopra, MD MPH、Wayne State University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
- Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.
- Moayyedi P, Marshall JK, Yuan Y, Hunt R. Canadian Association of Gastroenterology position statement: fecal microbiota transplant therapy. Can J Gastroenterol Hepatol. 2014 Feb;28(2):66-8. doi: 10.1155/2014/346590. No abstract available.
- Kwak S, Choi J, Hink T, Reske KA, Blount K, Jones C, Bost MH, Sun X, Burnham CD, Dubberke ER, Dantas G; CDC Prevention Epicenter Program. Impact of investigational microbiota therapeutic RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial. Microbiome. 2020 Aug 31;8(1):125. doi: 10.1186/s40168-020-00907-9.
- Dubberke ER, Lee CH, Orenstein R, Khanna S, Hecht G, Gerding DN. Results From a Randomized, Placebo-Controlled Clinical Trial of a RBX2660-A Microbiota-Based Drug for the Prevention of Recurrent Clostridium difficile Infection. Clin Infect Dis. 2018 Sep 28;67(8):1198-1204. doi: 10.1093/cid/ciy259.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年12月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2018年1月1日
研究注册日期
首次提交
2014年11月19日
首先提交符合 QC 标准的
2014年11月20日
首次发布 (估计)
2014年11月24日
研究记录更新
最后更新发布 (实际的)
2021年1月15日
上次提交的符合 QC 标准的更新
2020年12月23日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
RBX2660 (microbiota suspension)的临床试验
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McMaster Children's HospitalSt. Justine's Hospital完全的
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Ferring Pharmaceuticals招聘中
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McMaster Children's HospitalLondon Health Sciences Centre; St. Justine's Hospital完全的