CSP #2004 - Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death
研究概览
简要总结
The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.
详细描述
Clostridium difficile infection (CDI) is one of the most common nosocomial infections and is increasingly seen in non-hospitalized patients. Although more than 90% of patients have symptom resolution with a course of standard antimicrobial therapy, subsequent recurrence rates range from 15-30% (after the first CDI episode) to 40-50% (after the second and subsequent episodes). Fecal microbiota transplantation (FMT) has shown promise as an adjunct to standard antimicrobial therapy, reducing recurrence among FMT recipients to 15%.
The primary study goal is to assess the efficacy of FMT for the prevention of subsequent recurrent CDI, when administered after successful treatment of recurrent CDI with standard antimicrobial therapy. Secondary goals are to evaluate, the efficacy of FMT in terms of CDI severity, duration, the safety of FMT, and in the event of a positive study result, establish a mechanism for providing FMT within the VA system.
This study will enroll 390 participants. Participants will be randomized (1:1 ratio) to FMT or placebo, stratified by number of prior recurrent CDI episodes (1 versus >1). They will be assessed for symptoms of CDI, other study outcomes and any treatment-related adverse events at 2, 14, 28, 42, and 56 days, and month 3, 4, 5 and 6 after administration of the study treatment.
The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization.
Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis; Other clinical symptoms including ileus, toxic megacolon, or colectomy; plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test. Possible recurrence is defined as the same clinical manifestations as above, but without laboratory confirmation of C. difficile (stool test not sent, negative EIA toxin test result, or uninterpretable result).
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
- Triple (Participant, Care Provider, Investigator)
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
- •One or more episodes recurrent CDI (defined as > 3 loose/watery stools/24h for 2 consecutive days with CDI treatment, and not explained by another diagnosis plus laboratory confirmation of C. difficile; or ileus, or toxic megacolon plus laboratory confirmation of C. difficile, occurring within 90 days of a prior CDI episode with similar symptoms and laboratory confirmation)
- •Resolution or improvement of symptoms from most recent CDI episode, defined as no longer meeting the clinical definition for CDI for a 48 hour period during treatment, including not meeting the definition again after an initial improvement
- •Within the enrollment window: 2 days after completion of antimicrobial therapy for CDI (to allow for a washout period) to 14 days after completion of therapy or 30 days after the onset of CDI whichever is later.
- •Age 18 years
- •Enrolled in a Veterans Health Administration (VHA) facility
- •Able and willing to provide informed consent
排除标准
- •Unlikely to swallow capsules
- •Pregnancy, planning to be pregnant, or breastfeeding
- •Receipt of cytotoxic chemotherapy, intravenous or subcutaneous immune globulin, or confirmed neutropenia (absolute neutrophil count of < 1,000 cells/ L) within the past 3 months
- •Inflammatory bowel disease or other chronic diarrheal disease/fecal incontinence predating CDI
- •Ongoing antibiotic use other than those for the current episode of CDI
- •Life expectancy of < 8 weeks
- •Anaphylactic food allergy
- •Active enrollment in another research study on antibiotics, probiotics, or FMT without investigators approval
- •Presence of an ileostomy or colostomy
- •HIV with Clusters of Differentiation 4 (CD4) cell count < 200 cells/µL in prior 3 months
- •Decompensated cirrhosis
- •Bone marrow/peripheral blood stem cell transplant in the past year
- •Unlikely to follow study protocol
研究组 & 干预措施
1
Fecal Microbiota Therapy (FMT)
干预措施: Fecal Microbiota Therapy (FMT) (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death
时间窗: Within 56 days of randomization
The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test.
次要结局
- Frequency of Possible CDI Recurrences Within 6 Months of Randomization(Within 6 months of randomization)
- Definite Recurrent CDI(Within 56 days of randomization)
- Occurrence of Urgency Among All Possible CDI Recurrences.(within 6 months from randomization)
- Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR)(Within 56 days of randomization)
- Occurrence of Abdominal Pain Among All Possible CDI Recurrences.(Within 6 months of randomization)
- Possible Recurrent CDI(Within 56 days of randomization)
- Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization.(Within 6 months of randomization)
- Quality of Life at 56 Day(56 days from randomization)
- Death(Within 56 days of randomization)
- Diarrhea That is Negative for C. Difficile by EIA Toxin Testing But Positive by PCR(Within 56 days of randomization)
- Occurrence of Fecal Incontinence Among All Possible CDI Recurrences.(within 6 months from randomization)
- Occurrence of Altering Life Style Among All Possible CDI Recurrences(within 6 months of randomization)