Assessing the Impact of Antimicrobial Exposure and Infection Control Measures on the Spread of Vancomycin-resistant Enterococcus Faecium (VREf) - A Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- VREf - Patient rooms
研究概览
简要总结
The AEGON study is a German multicenter, prospective observational study. The study consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Part 1 focuses on the collection and analysis of rectal swabs from newly admitted VREf-negative patients at high risk of nosocomial VREf acquisition. Moreover, patients included into this part of the study will undergo in-depth documentation of clinical data if an antibiotic therapy is administered. Initiated antibiotic therapies will then be assessed by an AMS board (Antimicrobial Stewardship Board). In Part 2, environmental investigations will be performed in newly occupied single rooms of previously known VREf-positive patients. In addition, rectal swabs will be collected and data on antibiotic exposure of these patients will be documented in order to correlate the VRE contamination burden of surfaces with the intestinal VREf-load and antibiotic exposure.
详细描述
Current studies show that Vancomycin-resistant Enterococci (VRE) have become increasingly widespread throughout Germany in recent years, especially E. faecium (VREf). Healthy individuals can come into contact with VREf in various ways, for example via the food chain, contaminated drinking water or animal contacts. A possibly caused low-grade colonisation of the gastrointestinal tract with VREf (so-called low-level colonisation) can remain undetected during hospital admission using routine screening methods. The AEGON study, based on the use of state-of-the-art molecular diagnostics and comprehensive clinical data collection, will provide a detailed analysis of the factors involved in the rapid spread of VREf. In addition, diagnostic detection limits of common screening methods are determined by the use of additional diagnostics such as enrichment culture or molecular VREf detection.
The study is a German multicenter, prospective observational study and consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Part 1 focuses on the collection and analysis of rectal swabs from newly admitted VRE-negative patients at high risk of nosocomial VREf acquisition. Moreover, patients included into this part of the study will undergo in-depth documentation of clinical data if an antibiotic therapy is administered. Initiated antibiotic therapies will then be assessed by an AMS board. In Part 2, environmental investigations will be performed in newly occupied single rooms of previously known VREf-positive patients. In addition, rectal swabs will be collected and data on antibiotic exposure of these patients will be documented in order to correlate the VRE contamination burden of surfaces with the intestinal VREf-load and antibiotic exposure. The AEGON study, based on the use of state-of-the-art molecular diagnostics and comprehensive clinical data collection, will provide a detailed analysis of the factors involved in the rapid spread of VREf. In addition, diagnostic detection limits of common screening methods are determined by the use of additional diagnostics such as enrichment culture or molecular VREf detection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years
- •Patients with malignant primary disease and current inpatient admission to a normal ward with expected inpatient stay of at least 15 days
- •High risk of exposure to antibiotics during the stay
- •Written informed consent of the patient after clarification has been given
排除标准
- •Already known current or documented past colonisation or infection by VRE
- •Simultaneous participation in other studies is only an exclusion criterion if the other study explicitly excludes participation in observational studies or if the other study complicates the interpretation of the endpoints of AEGON (e.g. double-blind study on antibiotic use).
结局指标
主要结局
VREf - Patient rooms
时间窗: Change from baseline spread to spread at 10 weeks.
Primary Outcome for Cohort 2: Description of the spread of VREf in single rooms newly enrolled in known VREf-positive patients
VREf - Intestinal microbiota
时间窗: Baseline
Primary Outcome for Cohort 1: Rate of VREf intestinal colonization detected by enrichment culture or specific PCR at time of uptake not detected by standard culture methods
次要结局
- Standard culture VREf detection(baseline and every week up to 10 weeks max.)
- Antibiotics(baseline and every week up to 10 weeks max.)
- Inadequately administered antibiotics(baseline and every week up to 10 weeks max.)
- Adequate antibiotic(baseline and every week up to 10 weeks max.)
- Influence of antibiotic exposure duration(baseline and every week up to 10 weeks max.)
- Influence of antibiotic class(baseline and every week up to 10 weeks max.)
- VREf contamination(baseline at least every 72 hours up to max of 20 days.)
- Correlation of the antibiotic exposure(baseline at least every 72 hours up to max of 20 days.)
- Cleaning quality(baseline at least every 72 hours up to max of 20 days.)
- Contamination load of objects(baseline at least every 72 hours up to max of 20 days.)
研究者
Dr. med. Jörg Janne Vehreschild
Prof. Dr.
University Hospital of Cologne