Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Hospital Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 1
- 主要终点
- proportion of patients with a gram-negative colonization at admission
研究概览
简要总结
In this prospective observational multicenter study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10-day timeframe; determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote
详细描述
In this prospective multicenter observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Each participant will undego a oropharyngeal swab collection at day 0, day 5 and day 10 (or discharge), and a rectal swab at day 0 and day 10 or hospital discharge. The Gram-negative bacilli colonization will be identified, E. coli isolates will be studied in terms of phylogeny, antimicrobial and chlorhexidine susceptibility. The primary endpoint is to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization. The secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10 days timeframe; to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- •age > 18 years old
- •admitted in one of the participating surgery wards for elective or semi-emergent surgerical procedure or in one of the ICUs;
- •for an anticipated length of stay of 72h
排除标准
- •personal history of neck or face irradiation
- •bronchectasis;
- •patient's or proxies' opposition to participate
结局指标
主要结局
proportion of patients with a gram-negative colonization at admission
时间窗: day 1
proportion of patients in whom admission oropahryngeal sample will contain at least one gram-negative bacilli among Haemophilus influenzae, an enterobacteria, or a non-fermenting GNB.
次要结局
- incidence of the acquisition of a oropharyngela or rectal GNB colonization(during hospital stay or 10 days if still hospitalized)
- characterization of antimicrobial and chlorhexidine susceptibility of gram-negative isolates from oropharyngeal colonization(hospital stay or 10 days if still hospitalized)
- comparison of the predominant fecal flora with GNB oropharyngeal colonization(hospital stay or 10 days if still hospitalized)
- phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization(hospital stay or 10 days if still hospitalized)
- comparision of the genetic identity of the dominant E. coli rectal and orpohayrngeal colonization with potential nosocomial infections(hospital stay or 10 days if still hospitalized)