Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae (ESBLE) in a Geriatric Unit: an Interventional Prospective Noninferiority Non-randomized Double-blind Controlled Before and After Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 954
- 试验地点
- 2
- 主要终点
- Incidence density of acquired ESBLE
研究概览
简要总结
This is an interventional multicenter prospective noninferiority non-randomized double-blind controlled before and after study.
The aim of this study is to demonstrate that standard precautions alone are not inferior to contact precautions by comparing the incidence density of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae acquired in geriatric units before and after discontinuing contact precautions.
详细描述
Healthcare-associated infections (HAIs) are one of the main causes of morbidity and mortality worldwide. Extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae have become microorganisms frequently found in HAIs, which reduces the therapeutic possibilities.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (> 65 years old)
- •Patient hospitalized in geriatrics during the study period
- •Free and informed consent obtained from the patient (or his trusted person or legal representative) within 48 hours of its admission at the geriatric unit
- •Patient affiliated to a social security scheme
- •Non Inclusion Criteria:
- •Patient requiring contact precaution for an indication other than ESBLE (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC) on admission
- •Patient under legal protection
- •Person deprived of liberty
排除标准
- •Patient requiring contact precaution for an indication other than ESBL during the patient stay (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC)
- •Patient's stay period less than 4 days
研究组 & 干预措施
After discontinuation of contact precautions for ESBLE
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE
干预措施: Discontinuation of contact precautions for ESBLE (Other)
Before discontinuation of contact precautions for ESBLE
Implementation of contact precaution in addition to standard precaution for any patient carrying (infected or colonized) ESBLE
结局指标
主要结局
Incidence density of acquired ESBLE
时间窗: during 6 month period
Incidence density of acquired ESBLE in geriatric unit for 1000 days of hospitalization is calculated by dividing the number of acquired ESBLE by the number of days of patients' hospitalization multiplied by 1000 Acquisition of ESBLE is defined by a positive sample in patient on discharge day with a negative sample on admission in geriatric unit A positive sample is defined by the presence of at least one ESBLE on a clinical (infection) or screening (colonization) sample. The hospitalisation number is calculated as the cumulative length of stay of all patients at risk (= negative on admission).
次要结局
- The rate of compliance with hand hygiene in health care providers(Up to 3 months per health department)
- The rate of compliance with personal protective equipment(Up to 3 months per health department)
- Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS)(on the day of discharge of the geriatric unit, on average on the 11th day)
- Incidence density of acquired ESBLE by species during 6 month period(during 6 month period)
- Evaluation of the barriers to alcohol-based hand rub in case of non-compliance in health care providers(Up to 3 months per health department)