NCT07513285招募中2 期
A Phase 2 Interventional, Open-Label, Single-Arm Trial of Oral Ibezapolstat (ACX-362E) for Treatment and Reduction of Recurrent Clostridioides Difficile Infection in Patients With Multiple Recurrent Infections (IBZ-PATHFINDER)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 15
- 主要终点
- Evaluate the rate of CDI recurrence (rCDI)
研究概览
简要总结
Single-arm trial to evaluate the safety and efficacy of ACX-362E [ibezapolstat] in patients with recurrent C. difficile infection (CDI).
详细描述
Phase 2 multicenter, open-label, single-arm study is designed to evaluate the efficacy, safety, and tolerability of ibezapolstat in the treatment and reduction of recurrence of CDI in an adult patient population that has experienced ≥3 episodes of CDI within the past 12 months. Up to 20 participants will be treated with ibezapolstat 450 mg taken with food every 12 hours for 14 days (28 total doses) and followed for Clinical Cure (Day 16), Sustained Clinical Cure (Day 42), rate of CDI recurrence (Up to Week 24), and Extended Clinical Cure (ECC) (Up to Week 24).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CDI as defined by 1) the presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before study Day 1, AND 2) a stool test result positive for the presence of C. difficile free toxins
- •Three or more CDI episodes in the past 12 months, including the current episode, with each episode defined as ≥ 3 unformed stools in 24 hours associated with positive C. difficile toxin test.
- •At least 1 of the protocol-qualifying prior CDI episodes, not including the current episode, has been treated with oral vancomycin or with fidaxomicin
排除标准
- •Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure < 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon
- •Received more than 24 hours of dosing with antibiotics for the current CDI episode:
- •Received a live biotherapeutic product (LBP) (Rebyota® or Vowst™) within the past 12 weeks
- •Received or current use of anti-C. difficile antibodies, eg, IV immunoglobulin [IVIG], bezlotoxumab
- •Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with chronic diarrhea within 12 weeks before Baseline, or with a history of symptoms > 12 weeks before Baseline without evidence of mucosal healing on colonoscopy within the past year.
- •Active irritable bowel syndrome with chronic diarrhea in the past 12 weeks.
- •Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, other bacteria, a parasite, or a virus within the past 2 weeks
- •Major GI surgery (eg, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
- •Known current history of a severely compromised immune system
研究组 & 干预措施
Ibezapolstat
Experimental
Active investigational antibacterial agent
干预措施: Ibezapolstat (Drug)
结局指标
主要结局
Evaluate the rate of CDI recurrence (rCDI)
时间窗: Day 70
Evaluate the rate of CDI Clinical Cure (CC)
时间窗: Day 16
Evaluate the rate of Sustained Clinical Cure (SCC)
时间窗: Day 42
次要结局
- Assess the rate of CDI recurrence (rCDI)(Day 42)
- Assess the effects of ibezapolstat on quantitative changes to the fecal microbiome(Day 1 to Week 24)
- Assess time to resolution of diarrhea during the treatment period(Day 16)
- Assess the incidence of Extended Clinical Cure (ECC)(Weeks 8, 12, and 24)
- Assess the rate of CDI recurrence (rCDI)(Weeks 12 and 24)
研究者
研究点 (15)
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