CMTS0929 for Clostridioides Difficile Infection: a Prospective, Open-label, Single-arm Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The safety of CMTS0929
研究概览
简要总结
This is a prospective, open-label, single-arm study to explore the safety and the efficacy of CMTS0929 for patients with Clostridioides difficile infection (CDI).
详细描述
At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics and clinical data will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to enter the study:
- •At the time of informed consent, the age is between 18 and 75 years old (inclusive), including both males and non - pregnant, non - lactating females.
- •At the time of screening, meet the diagnostic criteria for Clostridioides difficile infection: a)There is a medical record proving a confirmed CDI before screening (laboratory tests show positive results for Clostridioides difficile or its toxins): positive results in Clostridioides difficile toxin detection (determined by EIAs) or colonoscopy indicating pseudomembranous colitis; or positive GDH with negative toxin results, along with obvious predisposing factors and diarrhea. b)Have an episode of CDI - related diarrhea, that is, having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6 - 7).
- •The subject or their legal representative provides informed consent, fully understands the purpose of the study, can communicate well with the researcher, and can understand and comply with all the requirements of this study.
排除标准
- •Subjects meeting any of the following exclusion criteria must be excluded from the study:
- •Subjects with immunodeficiency (such as HIV infection, or absolute neutrophil count < 0.5×10⁹/L, or total lymphocyte count < 0.5×10⁹/L, etc.), or those using immunosuppressants, or those using medium - to high - dose steroid hormones (≥20 g/d prednisone or equivalent steroid hormones).
- •Subjects with rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis that, as evaluated by the researcher, cannot undergo cTET.
- •Before screening, subjects are diagnosed or clinically suspected of having an infection with other pathogenic microorganisms in addition to Clostridioides difficile.
- •Within 6 months before screening, subjects have undergone major abdominal surgery (excluding laparoscopic cholecystectomy or appendectomy), or have previously undergone partial or total colectomy, or partial small intestine resection, or gastroduodenal surgery.
- •At the time of screening, the subject or legal representative refuses to use effective contraceptive measures within 3 months after the last treatment.
- •As judged by the researcher, the subject is not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subject.
研究组 & 干预措施
Treatment
Eligible subjects will receive treatment with CMTS0929. They will be administered one unit of the liquid via colonic transendoscopic enteral tube (cTET) for three consecutive days.
干预措施: CMTS0929 (Biological)
结局指标
主要结局
The safety of CMTS0929
时间窗: Four-week
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0: The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.)
次要结局
- The safety of CMTS0929(Immediately, One-week, Two-week, Eight-week, Twenty four-week)
- The complete response rate of CDI-related diarrhea(Four-week, Eight-week)
- The ultra-early complete response rate of CDI-related diarrhea(One-week post treatment)
- The early complete response rate of CDI-related diarrhea(Two-week post treatment)
- The non-response rate of CDI-related diarrhea(Two-week, Four-week, Six-week, Eight-week post treatment)
- The recurrence rate of CDI-related diarrhea(Four-week, Six-week, Eight-week, Twenty four-week)
- The major disease progression rate of CDI(Twenty four-week)
- The salvage/replacement treatment rate of CDI(Immediately, One-week, Two-week, Four-week, Eight-week, Twenty four-week)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University