A Phase 2, Randomized, Double-Blind, Comparator-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CRS3123 Compared With Oral Vancomycin in Adults With Clostridioides Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 20
- 主要终点
- Rate of Clinical Cure at the Test of Cure [TOC] Visit in the Intent-to-treat [ITT] Population
研究概览
简要总结
The purpose of this research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults > or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentrations and HRQoL outcomes of CRS3123 and additional efficacy endpoints as secondary objectives.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CRS3123 200 milligram
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 6-hour intervals for 10 days.
Due to the difference in dosing schedules between CRS3123 (twice a day) and the standard of care vancomycin (four times a day) and appearance of study drugs used in the 3 Arms, placebo will be used to match the total number of capsules in each arm.
干预措施: CRS3123 (Drug)
CRS3123 400 milligram
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 6-hour intervals for 10 days.
Due to the difference in dosing schedules between CRS3123 (twice a day) and the standard of care vancomycin (four times a day) and appearance of study drugs used in the 3 Arms, placebo will be used to match the total number of capsules in each arm.
干预措施: CRS3123 (Drug)
Vancomycin 125 milligram
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
干预措施: Active Comparator (Drug)
结局指标
主要结局
Rate of Clinical Cure at the Test of Cure [TOC] Visit in the Intent-to-treat [ITT] Population
时间窗: TOC/Day 12
Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., \<3 unformed bowel movements \[UBM\] \[Bristol Stool Scale score of 5, 6, or 7\] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day 12 visit.
次要结局
- Rate of Clinical Cure at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population(TOC/Day 12)
- Rate of Clinical Cure at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations(TOC/Day 12)
- Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population(TOC/Day 12)
- Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations(TOC/Day 12)
- Time to Resolution of Diarrhea Through Test of Cure (TOC) in the Microbiological-ITT (mITT) Population(Study Day 1 until the date of documented resolution, assessed up to TOC/Day 12)
- Time to Resolution of Diarrhea Through Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations(Study Day 1 until the date of documented resolution, assessed up to TOC/Day 12)
- Rate of Early Recurrence of Clostridioides Difficile Infection Through Day 40 in the Microbiological-ITT (mITT) Population(Post TOC/Day 12 visit through Day 40)
- Rate of Early Recurrence of Clostridioides Difficile Infection Through Day 40 in the Microbiologically Evaluable (ME) Population(Post TOC/Day 12 visit through Day 40)
- Rate of Global Cure in the Microbiological-ITT (mITT) Population(Post TOC/Day 12 visit through Day 40)
- Rate of Late Recurrence of Clostridioides Difficile Infection (Between Day 40 and Day 70) in the Microbiological-ITT (mITT) Population(Day 40 - Day 70)
- Rate of Late Recurrence of Clostridioides Difficile Infection (Between Day 40 and Day 70) in the Microbiologically Evaluable (ME) Population(Day 40 - Day 70)
- Rate of Recurrence of Clostridioides Difficile Infection Through Day 70 in the Microbiological-ITT (mITT) Population(Post TOC/Day 12 visit through Day 70)
- Rate of Recurrence of Clostridioides Difficile Infection Through Day 70 in the Microbiologic Evaluable (ME) Population(Post TOC/Day 12 visit through Day 70)
- Rate of Global Cure in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations(Post TOC/Day 12 visit through Day 40)