A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.
研究概览
简要总结
This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline.
- •Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
- •At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
- •Age ≥ 18 years.
- •Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.
排除标准
- •Evidence of colon/small bowel perforation at the time of study screening
- •Goals of care are directed to comfort rather than curative measures.
- •Moderate (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.
- •Known food allergy that could lead to anaphylaxis.
- •a. For subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration
- •Meeting criteria for severe, severe-complicated/fulminant CDI within 24 hours of planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2) hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or requiring pressors; (3) provider documentation of ileus or radiologic evidence of bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum creatinine level by ≥50% or new dialysis initiation; (5) serum lactate > 2.2 mmol/L; or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) criteria (which include heart rate > 90 beats per minute, respiratory rate > 20 breaths per minute or PaCO2 < 32 mmHg, temperature >38ºC or <36ºC, WBC > 12,000 cells/uL, <4,000 cells/uL, or >10% immature (band) forms).
- •Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.
研究组 & 干预措施
Single dose of PMT
干预措施: Penn Microbiome Therapy - 001 (Drug)
Single dose of PMT
干预措施: Penn Microbiome Therapy - 002 (Drug)
Single dose of PMT
干预措施: Penn Microbiome Therapy - 003 (Drug)
Two doses of PMT
Administered within 24 hours
干预措施: Penn Microbiome Therapy - 001 (Drug)
Two doses of PMT
Administered within 24 hours
干预措施: Penn Microbiome Therapy - 002 (Drug)
Two doses of PMT
Administered within 24 hours
干预措施: Penn Microbiome Therapy - 003 (Drug)
结局指标
主要结局
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.
时间窗: 8 weeks
Clinical resolution will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT. Clinical resolution will be defined as follows: * ≤ 4 stools per calendar day for the prior two days with no stool of Bristol stool scale type 7 * No additional stool tests with a positive EIA for C. difficile toxin since study enrollment * No additional prescription or use of anti-CDI antibiotics (unless given for prophylaxis) since study enrollment * No need for an additional
次要结局
- All-cause Mortality at 60-days Following Last FMT(60 days)
- Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT(30 Days)
- Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT(30 days)
- Colectomy or Diverting Ileostomy Within 30 Days After Last FMT(30 days)
- Bacteremia From Enrollment Until 30 Days After Last FMT(30 days)
- Hospital Admission Within 60 Days of Discharge From Index Hospitalization(60 days)
- All-cause Mortality at 30-days Following Last FMT(30 days)