跳至主要内容
临床试验/NCT02237859
NCT02237859Unknown4 期

Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection

Spectrum Health Hospitals1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
140
试验地点
1
主要终点
The incidence of recurrent Clostridium difficile infection

研究概览

简要总结

We are doing this research study to determine if taking vancomycin in addition to a broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium difficile infection.

详细描述

To determine whether prophylactic use of oral vancomycin reduces the incidence of recurrent Clostridium difficile infection (RCDI) in hospitalized patients admitted from their home or another health care facility (HCF) who are exposed to concurrent broad spectrum antibiotics.

This is a randomized research study, which means that the treatment you get will be chosen by chance, like flipping a coin. You will have a 50/50 chance of receiving one of the following:

  1. Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study medication).
  2. Group 2 (Placebo Group): single daily dose of placebo (a placebo will look just like the study medication, but contains no medication, only a substance like sterile water).

Depending on the group you are placed in (which is chosen by a computer), you will receive either a daily dose of the study medication or a daily dose of the placebo for a total of ten days. If you are discharged from the hospital prior to ten days, you will be given the study medication to complete outside of the hospital with written instructions.

A member of the Research staff will monitor you daily during the 10 days of treatment for any adverse reactions or any signs and symptoms of recurrent Clostridium difficile infection. If you are discharged prior to ten days, the monitoring will take place via telephone call daily until completion of the ten day treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • In patients >19 years of age
  • History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin during last episode.
  • Patients started on antibiotics during current admission for any other indication at any point of time during hospital course.

排除标准

  • Current diagnosis of CDI
  • First episode of CDI during this admission.
  • Allergy to Vancomycin or other known intolerance
  • h) Patient has received broad-spectrum antibiotics for more than 48 hours for this admission j) Incarceration

研究组 & 干预措施

Vancomycin

Experimental

Vancomycin 125 mg PO QD vs Placebo

干预措施: Vancomycin (Drug)

Vancomycin

Experimental

Vancomycin 125 mg PO QD vs Placebo

干预措施: fruit juice/placebo (Dietary Supplement)

结局指标

主要结局

The incidence of recurrent Clostridium difficile infection

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Maternowski

Physician

Spectrum Health Hospitals

研究点 (1)

Loading locations...

相似试验