NCT05831189已完成3 期
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 13
- 主要终点
- RBX2660-related treatment-emergent adverse events (TEAEs) after RBX2660 treatment delivered by colonoscopy through 8 weeks, or treatment failure
研究概览
简要总结
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explore the usability of RBX2660 in clinical practice for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660 treatment, each trial participant will be offered to undergo a structured interview.
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
- •have documented evidence of rCDI (≥1 recurrence after a primary CDI episode)
- •be undergoing antibiotic treatment for the qualifying rCDI episode that was diagnosed by a stool test for the presence of toxigenic C. difficile or C. difficile toxin
- •be eligible for FMT as judged by the investigator or current treatment guidelines for rCDI in the US
- •be a candidate for colonoscopy as judged by the investigator
排除标准
- •Use or planned use of systemic antibiotics for an indication other than the qualifying rCDI episode.
- •Current uncontrolled chronic diarrhea not related to CDI.
- •Receipt of CDI vaccine or treatment with CDI monoclonal antibodies within the past 12 months before screening.
- •Evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have a current colostomy or ileostomy
研究组 & 干预措施
RBX2660
Experimental
干预措施: RBX2660 (Drug)
结局指标
主要结局
RBX2660-related treatment-emergent adverse events (TEAEs) after RBX2660 treatment delivered by colonoscopy through 8 weeks, or treatment failure
时间窗: 8 weeks after RBX2660 treatment delivered by colonoscopy
Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure
时间窗: 8 weeks after RBX2660 treatment delivered by colonoscopy
次要结局
- Time to CDI recurrence from baseline through 8 weeks after RBX2660 treatment delivered by colonoscopy(8 weeks after RBX2660 treatment delivered by colonoscopy)
- TEAEs, including type, intensity, and causality(Up to 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Physician perception of patient benefit, as determined by Clinician Global Impression of Improvement (CGI-I) at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy(8 weeks after RBX2660 treatment delivered by colonoscopy)
- Recurrence of Clostridioides difficile infection (CDI) within 8 weeks after RBX2660 treatment delivered by colonoscopy.(Within 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Physician-experience, as determined by questionnaire, documenting subjective experience of investigators on usability of RBX2660 in clinical practice when delivered by colonoscopy(At Day 1 (baseline visit))
- Adverse events leading to death or intensive care unit (ICU) admission(Up to 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Patient-experience interview at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy(8 weeks after RBX2660 treatment delivered by colonoscopy)
- Serious adverse events (SAEs)(Up to 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Adverse events of special interest (AESIs): septic shock, toxic megacolon, colonic perforation, and emergency colectomy(Up to 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy.(Within 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Time to CDI Recurrence From Baseline Through 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy(8 weeks after RBX2660 treatment delivered by colonoscopy)
- Physician-experience, as Determined by Questionnaire, Documenting Subjective Experience of Investigators on Usability of RBX2660 in Clinical Practice When Delivered by Colonoscopy(At Day 1 (baseline visit))
- Physician Perception of Patient Benefit, as Determined by Number of Participants With Clinician Global Impression of Improvement (CGI-I) at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy(8 weeks after RBX2660 treatment delivered by colonoscopy)
- Patient-experience Interview at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy(8 weeks after RBX2660 treatment delivered by colonoscopy)
- Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment(Up to 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Number of Participants With Serious Adverse Events (SAEs)(Up to 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Number of Participants With Any Adverse Events of Special Interest (AESIs)(Up to 8 weeks after RBX2660 treatment delivered by colonoscopy)
- Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission(Up to 8 weeks after RBX2660 treatment delivered by colonoscopy)
研究者
研究点 (13)
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