Study of the Fecal Relative Abundance (RA) of ESBL-producing Enterobacteriaceae (ESBL-PE) in Intensive Care (BLSE-REA) : What Are the Factors Influencing the Fecal RA of ESBL-PE in ICU ?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Changes in fecal ESBL-PE RA in the ICU
研究概览
简要总结
Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) pose a major problem among antimicrobial resistance. The worldwide spread of theses bacteria may be responsible for 10 million death in 2050. Infection with ESBL-PE are associated with a worse prognosis because of delay in the start of adequate antibiotic treatment, especially for severe infections. It has been proposed to identify colonized patients to predict the risk of infection and the risk of nosocomial cross transmission.
This qualitative approach has limit as only 5 to 20% of patients will develop an infection with ESBL-PE. The fecal relative abundance (RA) of ESBL-PE is a ratio of ESBL-PE among enterobacteriaceae that could identify high-risk patients of infection or cross transmission. ESBL-PE RA may be highly variable in patient with antibiotic exposure depending on the molecule received but dynamic data is missing.
The aim of this study is to identify the factor that influence the fecal RA of ESBL-PE in ICU and to evaluate the association between different level of fecal RA and infection or cross transmission with an ESBL-PE.
详细描述
Antimicrobial resistance is rising since decades with a risk of million of death in the future. Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) have expanded exponentially since 15 years and represent with Carbapenemase-PE one of the major challenges in resistance control. The burden of ESBL-PE infections is major in intensive care units (ICU) because of the delay to identify an effective antibiotic treatment (highly associated with outcome) and because of a higher risk of nosocomial cross transmission.
Identification of digestive carrier of ESBL-PE is based on a qualitative result that categorize the patient as a carrier or as non-carrier. This result makes it impossible to individualize the measures to be taken for an ESBL-PE carrier.
Prevention of cross transmission has no formal guideline. Some practitioners in ICU have stopped to detect for ESBL-PE carriage (specially when prevalence is low) and other prefer to close the ward (specially during outbreak).
Empiric treatment of most infections in ESBL-PE carrier are based on last-resort antibiotic (i.e. carbapenem) until microbiological results of a clinical simple is available.
A quantitative approach based on fecal relative abundance (RA) of ESBL-PE (ratio between ESBL-PE and enterobacteriaceae) has been proposed to individualize the risk of urinary tract infection (UTI) for ambulatory patients. In this setting, a fecal carriage with a very low RA of ESBL-PE safely rule out a risk of infection with ESBL-PE and patients with a high RA had an increased risk of UTI infection with ESBL-PE. Large variations of RA ESBL-PE carriage was observed and prediction of the level of RA was not possible for a patient.
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
- None
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
- •Age ≥ 18 years
- •Positive sample for ESBL-PE at admission of during ICU stay
- •Patient's or relative's consent
排除标准
- •Women pregnant, parturient or breast-feeding during the study period
- •Patient deprived of liberty by judicial or administrative decision
- •Patient undergoing psychiatric care under duress
- •Patient subject to a legal protection measure
- •Patient with no social security coverage
结局指标
主要结局
Changes in fecal ESBL-PE RA in the ICU
时间窗: Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Factors associated with changes in the RA of ESBL-PE fecal carriage will be analyzed. RA is expressed by the ratio of ESBL-PE and total enterobacteriaceae.
次要结局
- Association between changes in ESBL-PE RA in fecal samples and ESBL-PE infection(Day 0, 3, 5, 7, 10, 14 and weekly till day 30.)
- Association between changes in ESBL-PE RA in fecal samples and ESBL-PE cross-transmission(Day 0, 3, 5, 7, 10, 14 and weekly till day 30.)
- Association between changes in ESBL-PE RA in fecal samples and multiple-site colonization(Day 0, 3, 5, 7, 10, 14 and weekly till day 30.)
- Association between changes in ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE(Twice a week till day 30.)
- Comparison of changes in ESBL-PE RA between different bacteria species during ICU stay(Day 0, 3, 5, 7, 10, 14 and weekly till day 30.)
- Incidence of high level of EBSL-PE RA in ICU fecal carriers(Day 0, 3, 5, 7, 10, 14 and weekly till day 30.)