Phase III,randomized,double-blinded Clinical Trial to Evaluate the Effectiveness and Safety of Oral Vancomycin Vs Placebo in the Prevention of Recurrence of C.difficile Infection in Patients Under Treatment with Systemic Antibiotic Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
研究概览
简要总结
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin (experimental treatment), multicentric, national, double-blinded, controlled with placebo. The main objective is to evaluate the effectiveness of treatment with oral vancomycin to reduce the incidence of Clostridioides difficile infection (CDI) in patients who suffered previous CDI and who need further hospitalization and treatment with systemic antibiotic therapy in the 90 days after the first CDI.
详细描述
As secondary objectives the investigators intend to:
- Evaluate the effectiveness of the treatment with oral vancomycin as part of the prophylaxis arsenal to prevent ICD in patients with previous ICD episodes stratified by the number of previous recurrences.
- Compare the severity of recurrences in both study groups.
- Compare the effectiveness of the treatment with oral vancomycin depending on the type of systemic antibiotic therapy prescribed.
- Evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of secondary effects and difficulty in therapeutic compliance.
- Evaluate if the treatment with oral vancomycin has an effect in diminishing the severity of ICD recurrences.
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
- •Age equal or superior to 18 years
- •Previous history of Clostridioides difficile infection in the 90 days before the study enrolment
- •Need for hospitalization and need of antibiotic therapy
- •Signature of informed consent
排除标准
- •Woman of childbearing age, pregnant woman, or breastfeeding woman
- •Hypersensitivity to vancomycin
- •Inability to comply with study protocol
- •Critically ill condition or life expectancy less than 30 days
- •Patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea
- •Fulfilment of the criteria for diarrhea or diagnosis of CDI at the time of assessment for eligibility or in the previous 3 days
- •Therapy with oral vancomycin or any other agent with activity against C. difficile for >48 hours in the previous 3 days;.
- •Prophylaxis with oral vancomycin or any other agent with activity against C. difficile within the 70 days before the assessment for eligibility
- •Systemic antibiotic therapy for 72 hours or more before the recruitment
- •Ongoing enrolment in another RCT evaluating the effectiveness of other drugs
- •Estimated use of systemic antibiotic therapy for more than 4 weeks
研究组 & 干预措施
Intervention group
A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days.
干预措施: Oral Vancomycin (Drug)
Placebo group
A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
时间窗: 60 days after the beginning of the intervention
Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.
次要结局
- Effectiveness of treatment with oral vancomycin depending on antibiotic therapy(60 days after the beginning of the intervention)
- Effectiveness of treatment with oral vancomycin according to the number of previous recurrences(60 days after the beginning of the intervention)
- Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence(60 days after the beginning of the intervention)
- Tolerance and safety of treatment with oral vancomycin(60 days after the beginning of the intervention)
研究者
Julia Orígüen
Julia Origüen Sabater, MD, PhD, Principal Investigator.
Hospital Universitario 12 de Octubre