2024-513490-45-00招募中3 期
VANCALLO - Prevention of C. difficile infections by oral vancomycin in patients treated for allogeneic hematopoietic stem cell transplantation, a randomized double-blind placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 336
- 试验地点
- 6
- 主要终点
- Clostridium difficile infection, occurring between inclusion and discharge from hospitalization or the end of treatment with vancomycin or placebo (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 unformed stools/day) with detection of CD (GDH) and free toxin in the stools by enzyme immunoassay without argument for another etiology of diarrhea or existence of pseudomembranous colitis at endoscopy, at colectomy or at autopsy.
研究概览
简要总结
Evaluate the effectiveness of primary prophylaxis with oral vancomycin on the prevention of Clostridium difficile infections in patients hospitalized for allogeneic HCT transplantation.
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
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥15 years
- •Patient hospitalized for less than 72 hours to receive an allograft of HSC, whatever the indication and packaging,
- •for men and women of childbearing age: use of effective contraception (failure rate less than 1% per year) throughout the Research and up to 1 month after the end of treatment (see point 6.1 Inclusion criteria)
- •Have given consent for participation in the study.
- •Beneficiary of health insurance
排除标准
- •Documented allergy or adverse reactions to vancomycin
- •Pregnancy and breast feeding
- •Clostridium difficile infection within 30 days preceding inclusion or on the day of inclusion
- •History of total colectomy and/or chronic inflammatory bowel disease
- •Progressive diarrhea at inclusion regardless of the etiology
- •Digestive decontamination protocol during the transplant procedure
- •Participation in another medicinal intervention research involving humans or being in the exclusion period following previous research involving humans, if applicable
结局指标
主要结局
Clostridium difficile infection, occurring between inclusion and discharge from hospitalization or the end of treatment with vancomycin or placebo (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 unformed stools/day) with detection of CD (GDH) and free toxin in the stools by enzyme immunoassay without argument for another etiology of diarrhea or existence of pseudomembranous colitis at endoscopy, at colectomy or at autopsy.
Clostridium difficile infection, occurring between inclusion and discharge from hospitalization or the end of treatment with vancomycin or placebo (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 unformed stools/day) with detection of CD (GDH) and free toxin in the stools by enzyme immunoassay without argument for another etiology of diarrhea or existence of pseudomembranous colitis at endoscopy, at colectomy or at autopsy.
次要结局
- - Clostridium difficile infection, occurring between inclusion and W12, defined by diarrhea (> 3 unformed stools/day) with detection of CD and free toxin in the stools by immunoenzymatic method without argument for another etiology in diarrhea or presence of pseudomembranous colitis at endoscopy, colectomy or autopsy.
- - Time between inclusion and Clostridium difficile infection as defined in the primary endpoint, in a maximum window up to W5
- - Clostridium difficile infection, occurring between inclusion and discharge from hospitalization or the end of treatment with vancomycin or placebo (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 unformed stools/day) with detection of toxigenic CD by PCR without argument for another etiology of diarrhea or existence of pseudomembranous colitis at endoscopy, colectomy or autopsy.
- - Risk factors for CD infection: type of packaging, antibiotics received, presence of toxigenic strain on D0 of treatment (D0V), composition of the microbiota
- - Severity factors of CD infections occurring during the procedure
- - Microbiologically documented bacterial infection(s) (regardless of the infectious source) occurring during treatment with 125 mg of vancomycin (i.e. up to 5 weeks maximum)
- - Acquisition of rectal carriage of vancomycin-resistant Enterococcus (VRE) between randomization and the end of treatment (discharge from hospitalization or W5 maximum) measured by rectal swab
- - Study of the intestinal microbiota at inclusion, during treatment (14 days after initiation of treatment, i.e. W2), at the end of treatment (W5 or before discharge from hospitalization) and remotely (W12) as part of the ancillary study
- - Occurrence of nosocomial clusters of CD infection at W12 defined as the occurrence of at least 2 cases of CDI over a period of time defined according to the incidence usually observed in the investigating center
- - Occurrence of acute or chronic GVHD grade 2-4 at M12
- - Time between inclusion and relapse of the hematological disease, or the date of last news (maximum M12)
- - Mortality rate linked to the transplant procedure (TRM) at W5
- - Delay between inclusion and death, or the date of last news (maximum M12)
- - Proportion of adverse effects during protocol monitoring
研究者
Inès BOUSSEN
Scientific
Assistance Publique Hopitaux De Paris
研究点 (6)
Loading locations...
相似试验
招募中
不适用
Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides DifficileC. DifficileNCT05389904Brigham and Women's Hospital300
已完成
不适用
Effect of Expanding (Gloving) Barrier Precautions for Reducing Clostridium Difficile Acquisition (and Infection) in VAClostridium DifficileNCT04036058VA Office of Research and Development780
已完成
4 期
Screening to Prophylax Against Clostridium Difficile Infection -Clostridium Difficile InfectionNCT02996487William Beaumont Hospitals1,294
已完成
不适用
Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of InfectionsClostridium DifficileNCT03223415Yves Longtin4,138
撤回
3 期
Fecal Microbiota Transplantation for Primary Clostridium Difficile DiarrheaClostridium DifficileNCT02801656Memorial University of Newfoundland