Two-Center Intervention Study to Evaluate the Impact of Rapid Molecular Screening on Nosocomial Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,400
- 试验地点
- 4
- 主要终点
- To determine if a ≥ 50 % reduction of incidence of nosocomial MRSA acquisition can be observed after replacing culture by PCR for universal MRSA screening of patients upon admission to high incidence units in two acute care hospitals
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a novel PCR-based laboratory test for rapid detection of MRSA carriers to prevent transmission of MRSA in the Belgian acute care hospital setting.
详细描述
Methicillin-resistant Staphylococcus aureus (MRSA) strains have become endemic pathogens in acute and chronic healthcare facilities in Belgium. MRSA infection is causing increased public concern as it carries a significant risk of morbidity, mortality and has been linked to substantial excess healthcare costs.
Efficient control of MRSA transmission within healthcare facilities critically depends on screening for and isolation of MRSA carriers among admitted patients. Active surveillance cultures for MRSA are now part of clinical practice recommendations both in Europe and the USA. Indeed, studies have indicated that up to 70 % of the patient reservoir for MRSA among hospitalized patients can only be detected by active sampling of muco-cutaneous colonization sites. There is an urgent public health need for early and reliable detection of carriers of MRSA among patients admitted to healthcare facilities, to inform patient isolation and decontamination procedures, and thereby more effectively control cross-infection
The general objectives of this intervention study to be conducted in two large Belgian hospitals are to measure the impact of rapid (< 3 h) PCR detection of MRSA carriage upon patient admission on shortening the delay to implement contact isolation precautions for carriers and reducing nosocomial MRSA transmission to patients admitted in the same wards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •All patients admitted for more than 48h to a ward in which evaluation in the previous baseline period met the following:
- •> 80 % compliance with admission and discharge conventional culture screening, for the pooled admissions to all study wards;
- •> 80 % compliance with additional MRSA contact isolation procedures, based on a sample of 50 patient care contact observations per hospital in all study wards;
- •pooled incidence of nosocomial MRSA acquisition ≥ 1.5 new cases /100 at risk admissions in the study wards.
排除标准
- •Patients staying 48h or less in the study wards
结局指标
主要结局
To determine if a ≥ 50 % reduction of incidence of nosocomial MRSA acquisition can be observed after replacing culture by PCR for universal MRSA screening of patients upon admission to high incidence units in two acute care hospitals
时间窗: 5-10 months
次要结局
- Median time required for detection of MRSA carriage after admission(5-10 months)
- Median time required for starting isolation of MRSA carriers(5-10 months)
- Number of patient-days of MRSA carrier stay in non-isolated conditions(5-10 months)
- MRSA nosocomial infection rate(5-10 months)
- MRSA cross-transmission rate(5-10 months)
- Sensitivity and specificity of PCR vs conventional MRSA screening by culture(10 months)