An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-transplant Patients Treatment for C. Difficile Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 9
- 主要终点
- Response to antibiotic treatment for CDI: complications
研究概览
简要总结
The primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients.
详细描述
The primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients. This includes treatment success, recurrence, and complications in a prospectively followed cohort of solid organ and hematopoietic stem cell transplant patients. Patients who develop CDI within 2 years after transplantation will be enrolled and followed prospectively for 90 days after enrollment. Specimens of stool and serum collected within 48 hours of initiation of treatment will be stored locally for future epidemiologic studies to examine the immunologic and microbiologic risk factors for relapse and treatment failure, as well as complications of CDI in the transplant population. Response rates will be classified by organ type, hematopoietic stem cell transplant typ, treatment regimen, and immunosuppressive regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Signed informed consent
- •Transplant recipient (solid organ, stem cells, or bone marrow) within past 2 years
- •Currently diagnosed with first CDI after transplant, defined by (1) presence of diarrhea (at least 3 loose stools within a 24-hour period), AND (2) detection of C. difficile cytotoxin in stools by cytotoxin assay, or toxigenic culture, or polymerase chain reaction (PCR) testing for toxin, or enzyme immunoassay, or endoscopic presence of pseudomembranes with the detection of C. difficile in tissue biopsies
排除标准
- •Previous episode of CDI anytime after transplant
- •Current treatment for another infectious cause of diarrhea (bacterial, viral, or parasitic) at the time of the current CDI diagnosis
结局指标
主要结局
Response to antibiotic treatment for CDI: complications
时间窗: 90 days
The study will collect the incidence of specific complications as assessed by the site investigator: perforation of the colon; development of toxic megacolon; need for abdominal surgery related to CDI; transfer to the ICU with CDI; death from CDI-related cause.
Response to antibiotic treatment for CDI: reinfection
时间窗: 90 days
A new episode of CDI after clinical cure and beyond 4 weeks after treatment initiation
Response to antibiotic treatment for CDI: clinical cure
时间窗: 90 days
The planned first course of CDI treatment was completed with resolution of symptoms or less than 3 loose stools per day for at least two consecutive days maintained until end of treatment and two days after treatment course ended.
Response to antibiotic treatment for CDI: sustained clinical cure
时间窗: 90 days
Clinical cure achieved and maintained for 40 days post treatment initiation without recurrences, complications, ICU with CDI, or death as defined below
Response to antibiotic treatment for CDI: global cure
时间窗: 90 days
Clinical cure achieved and maintained for 90 days post treatment initiation without recurrences, complications, including ICU with CDI, or death as defined below.
Response to antibiotic treatment for CDI: relapse
时间窗: 90 days
A new episode of CDI after clinical cure and within 4 weeks after treatment initiation.
次要结局
- Describe patients who are successfully treatment for CDI(90 days)
- All-cause mortality(90 days)
- Assay differences across sites(90 days)
- Response to treatment for CDI (as defined above) by treatment regimen(90 days)
- Response to treatment for CDI (as defined above) by type of transplant (solid organ vs. hematopoietic/stem cell)(90 days)
- Describe differences in antibiotic regimens and other CDI treatments across geographic regions (US, Europe, South America)(90 days)