NCT06237452招募中3 期
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of 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
- 招募中
- 入组人数
- 852
- 试验地点
- 386
- 主要终点
- CDI Recurrence Rate at Week 8
研究概览
简要总结
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(For enrollment in Stage 1: recurrent CDI population):
- •Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months
- •Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):
- •Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI
- •OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:
- •Age ≥ 65 years
- •Kidney dysfunction, defined as estimated creatinine clearance < 60 mL/min/1.73 m^2 at the time of the qualifying CDI episode
- •History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study
- •History of a prior CDI episode between 6 and 12 months prior to enrollment
- •Immunosuppression due to an underlying disease or its treatment
- •Has undergone solid organ or hematopoietic stem cell transplantation
- •Key Inclusion Criteria (For enrollment in Stage 1 or 2):
- •The qualifying episode of CDI must meet all the following criteria:
- •New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days
- •CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI
- •Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory
- •Diarrhea considered unlikely to have another etiology
- •Prior to receiving any study medication, the participant should:
- •Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration.
- •Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, < 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days
- •Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing
- •Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization
排除标准
- •(For both Stage 1 and Stage 2):
- •History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI
- •Known or suspected toxic megacolon or small bowel ileus at the time of randomization
- •History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis
- •Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode
- •Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug
- •Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)
- •Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.)
- •Absolute neutrophil count (ANC) of < 0.5 ×10^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC < 1.0 × 10^9 cells/L
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
干预措施: Placebo (Biological)
VE303
Experimental
Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
干预措施: VE303 (Biological)
结局指标
主要结局
CDI Recurrence Rate at Week 8
时间窗: 8 weeks
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
次要结局
未报告次要终点
研究者
研究点 (386)
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