A Phase 2 Clinical Study of REC-3964 in Adults for the Reduction of Recurrent Clostridioides Difficile Infection (CDI)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of Participants With Survival Without Recurrence or Requirement for Additional Clostridioides Difficile Infection (CDI) Treatment
研究概览
简要总结
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides difficile infection (CDI).
详细描述
Study was terminated due to sponsor decision. This decision was not related to safety concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 115 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrhea associated with a positive stool test for C. difficile toxin[s] prior to the preceding curative treatment.
- •The CDI episode, severe or otherwise, must have resolved after receiving vancomycin with a standard duration of treatment. The participant must be randomized within 2 days of completing the preceding curative treatment.
- •Have high risk for rCDI (a recurrent CDI episode within the last 6 months, age ≥65 years, immunocompromised state, or severe CDI with resolution prior to enrollment into the study).
排除标准
- •Have an active, symptomatic, chronic diarrheal illness from other causes, such as ulcerative colitis or Crohn's disease.
- •Diarrhea that requires on-study treatment with agents that would confound the interpretation of the study results.
研究组 & 干预措施
REC-3964 High-dose
Participants will receive 500 mg REC-3964 q12h REC-3964 250 mg capsules
干预措施: REC-3964 (Drug)
REC-3964 Low-dose
Participants will receive 250 mg REC-3964 q12h REC-3964 250 mg capsules
干预措施: REC-3964 (Drug)
结局指标
主要结局
Number of Participants With Survival Without Recurrence or Requirement for Additional Clostridioides Difficile Infection (CDI) Treatment
时间窗: 8 weeks
Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin or requirement for additional CDI treatment during the 8-week Follow-up Period after cure of preceding CDI with initial curative treatment.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 8 weeks
A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
Number of Participants With Related TEAEs
时间窗: Up to 8 weeks
A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An Investigator who was qualified in medicine determined relationship to the study drug for each AE (unrelated or related). The Investigator decided whether, in his or her medical judgment, if there was a reasonable biological possibility that the event may have been caused by the study drug.
Number of Participants With Serious TEAEs
时间窗: Up to 8 weeks
A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A Serious TEAE was defined as results in death, immediately life-threatening, requires in-participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity in conducting activities of daily living for at least 28 days, results in a congenital abnormality or birth defect, or an important medical event that may jeopardize the participant or may require medical intervention.
Number of Participants With TEAEs Leading to Study Drug Discontinuation
时间窗: Up to 8 weeks
A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
次要结局
- Rate of Recurrent Clostridioides Difficile Infection (rCDI)(8 weeks)
- Time to Recurrence of rCDI(Up to 8 weeks)
- Number of Participants With Severe rCDI(Up to 8 weeks)
- Number of Participants With rCDI Who Had Associated Hospital Admissions(Up to 8 weeks)
- Maximum Observed Plasma Concentration (Cmax) of REC-3964(Pre-dose, 1 hour, 3 hours, and 6 hours post morning dose on Day 1 and Day 15)
- Time to Maximum Plasma Concentration (Tmax) of REC-3964(Pre-dose, 1 hour, 3 hours, and 6 hours post morning dose on the Day 1 and Day 15)
- Trough Plasma Concentration (Ctrough) of REC-3964(Pre-dose on Day 15)