Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients (Decency-RCT): a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.
研究概览
简要总结
The goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. The ultimate goal is to conduct an appropriately-powered RCT to determine the optimal method for reducing C difficile infection in colonized patients.
详细描述
In this study, patients will be screened for C. difficile colonization
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)
盲法说明
Blinding will be done in a double-blind fashion. The patients, their caregiver, and the investigator will be blinded to the study treatment.
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
- •Adult patients of 18 years of age or older identified as asymptomatic carriers of C. difficile (i.e. not meeting case definition of C. difficile infection, see below)
- •Started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection
- •Patient must have vitals (heart rate, blood pressure, temperature), estimated creatinine clearance (using the Chronic Kidney Disease Epidemiology equation (CKD-Epi)) and a complete blood count available within 24 hours of enrolment
排除标准
- •On a course of systemic antibiotics that had been started more than 72 hours ago (as current evidence suggests that the earlier probiotics are started, the more efficacious they are)
- •Patient with C. difficile, i.e. presence of diarrhea (three or more loose or watery stools within 24 hours), or fevers or hypotension from C. difficile infection
- •Any patients with contra-indications to probiotics or vancomycin:
- •Immunosuppressed (primary or acquired immunodeficiency, including AIDS (defined as AIDS defining condition or cluster of differentiation 4 (CD4) nadir of <200/ul), hematologic malignancies, long-term systemic corticosteroid treatment, active treatment with chemotherapeutic agents or biologicals, autoimmune diseases, nephrotic syndrome)
- •Structural heart disease (e.g. atrial septal defect, ventricular septal defect)
- •Gastroesophageal or compromised gut integrity (e.g. short gut syndrome, intestinal injury or dysfunction, inflammatory bowel diseases including current or past history of Crohn's disease and ulcerative colitis)
- •Patients on systemic aminoglycosides, ethacrynic acid, polymixin B, or colistin.
- •Prior or current hearing loss
- •Female patients with known pregnancy or who are planning to get pregnant, or who are breastfeeding
- •Patients with end-stage renal diseases defined as an estimated glomerular filtration rate of <15ml/min, or absence of a current estimated creatinine clearance
- •History of an allergic reaction to one of the study drugs, or sensitivity to milk
- •Patients started on probiotics or oral vancomycin while in hospital
研究组 & 干预措施
Vancomycin & probiotic placebo
Vancomycin 125 mg orally every 12 hours plus probiotic placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.
干预措施: Vancomycin (Drug)
Vancomycin & probiotic placebo
Vancomycin 125 mg orally every 12 hours plus probiotic placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.
干预措施: Probiotic Placebo (Drug)
Probiotic & vancomycin placebo
Culturelle probiotic 20 billion active units orally every 12 hours plus vancomycin placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.
干预措施: Culturelle (Dietary Supplement)
Probiotic & vancomycin placebo
Culturelle probiotic 20 billion active units orally every 12 hours plus vancomycin placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.
干预措施: Vancomycin Placebo (Drug)
Probiotic placebo & vancomycin placebo
Vancomycin placebo orally every 12 hours and Culturelle placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.
干预措施: Vancomycin Placebo (Drug)
Probiotic placebo & vancomycin placebo
Vancomycin placebo orally every 12 hours and Culturelle placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.
干预措施: Probiotic Placebo (Drug)
结局指标
主要结局
Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.
时间窗: 1 year
Feasibility will be assessed using the following parameters: Proportion of eligible participants screened that are randomized within 72 hours of antibiotic exposure (goal ≥ 90%) * Proportion of participants receiving all doses of study medication (goal ≥ 90%) * Proportion of participants with complete follow up at 14 days (goal ≥ 95%)
Development of C difficile associated diarrhea within 14 days of randomization
时间窗: 1 year
Development of C difficile associated diarrhea within 14 days of randomization to one of the treatment arms as defined by the Provincial Infectious Diseases Advisory Committee (PIDAC)
次要结局
未报告次要终点