跳至主要内容
临床试验/NCT04014608
NCT04014608已完成不适用

Admission Toxigenic C. Difficile Surveillance to Reduce Hospital Onset C. Difficile Infection (CDI)

NorthShore University HealthSystem1 个研究点 分布在 1 个国家目标入组 148,549 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148,549
试验地点
1
主要终点
Change in Hospital Onset C. difficile Infection

研究概览

简要总结

Background: Clostridioides (formerly Clostridium) difficile Infection (CDI) is a persistent healthcare issue. In the US, CDI is the most common infectious cause of hospital-onset (HO) diarrhea.

Objective: Assess the impact of admission testing for toxigenic C. difficile colonization on the incidence of clinical disease.

Design: Pragmatic stepped-wedge Infection Control initiative. Setting: NorthShore University HealthSystem (NorthShore) is a four-hospital system near Chicago, Illinois.

Patients: All patients admitted to the four hospitals during the initiative. Interventions: From September 2017 through August 2018 the investigators conducted a quality improvement program where admitted patients had a peri-rectal swab tested for toxigenic C. difficile. All colonized patients were placed in contact precautions.

Measurements: The investigators tested admissions who: i) had been hospitalized within two months, ii) had a past C. difficile positive test, and/or iii) were in a long-term care facility within six months. The investigators measured compliance with all other measures to reduce the incidence of HO-CDI.

Limitations: This was not a randomized controlled trial, and multiple prevention interventions were in place at the time of the admission surveillance initiative.

详细描述

Background:

Clostridium difficile infection (CDI) remains a constant, even increasing, clinical infection threat in the United States and Europe. New preventive strategies are urgently needed. Current control measures do not target asymptomatic carriers, despite evidence that they can contaminate the hospital environment and health care workers' hands; a risk to potentially transmit C. difficile to other patients. Of special importance is that not only is disease prevalence increasing, but severity of illness and mortality also is on the rise. The investigators have implemented many interventions at our healthcare system including bleach cleaning of rooms with CDI patients, monitoring of environmental services' room cleaning, hand hygiene education and even UV light disinfection of rooms harboring CDI patients, and none have been consistently effective. The investigators believe that CDI is much like methicillin resistant Staphylococcus aureus (MRSA), in that many more patients are colonized than infected, and one (perhaps the optimal) way to curtail disease is to interrupt transmission by identifying carriers and placing them into contact (glove and gown) precautions.

The investigators propose to test this hypothesis with a quality improvement program study at NorthShore. The primary goal is to demonstrate that surveillance testing for C. difficile colonization at the time of admission and contact precaution isolation of those positive will reduce spread of the organism as well as lower clinical CDI. The investigators secondary goals are to demonstrate a reduction in C. difficile infection incidence after implementation of this program and demonstrate that such a program is cost effective.

Study Methods:

We have collected CDI disease rates for 10 years. One of our hospitals admits a high number of patients from long term care facilities (LTCFs) and currently has a rate of infection at 11 cases/10,000 patient days, and this facility served as a pilot site in the program initiative. The nosocomial CDI rate at this facility had been rising during the first quarter of 2016. The investigators plan to introduce peri-rectal (intra-anal) swab testing for C. difficile on all admissions accompanied by isolation of positive patients, which the investigators hypothesize will lower the rate to 3 cases/10,000 patient days. In absolute numbers, the goal is to reduce the rate from 4 nosocomial cases per month down to 1 nosocomial case per month. This is intended to provide a sample size that can demonstrate a level of significance at p<.05 for disease reduction with the intervention when compared to the same time frame prior to the admission testing intervention.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Hospital admission

排除标准

  • 未提供

结局指标

主要结局

Change in Hospital Onset C. difficile Infection

时间窗: Nine months of a pilot program at one hospital and one year of all 4 hospital application of admission screening

An altered incidence of this hospital acquired infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Protocol for Admission Toxigenic C. Difficile... | 临床试验