Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,289
- 主要终点
- The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers
研究概览
简要总结
Antimicrobial resistance has emerged as a global threat, and multidrug resistance organisms (MDROs) form one of the foremost challenges in the setting of decompensated cirrhosis. In a worldwide study, a high prevalence (34%) of infection with MDR bacteria in patients with cirrhosis and associated with higher in-hospital mortality.
Previous study indicated that the pattern of colonized bacteria in heterogeneous and the colonization by MDROs is associated with increased risk of infection. Effort should be made to reduce the spread of MDR bacteria and improvement in prognosis in patents with cirrhosis. Currently, strategies suggested to prevent the spread of MDROs in cirrhosis, including rapid microbiological tests, new first-line antibiotic schedules, infection control practices and epidemiological surveillance.
Thus, for the aims of this cohort study are as following. Firstly, to characterize the burden, dynamics and risk factors associated with rectal colonization by MDROs in patients with cirrhosis. Secondly, to completely characterize the risk that asymptomatic carriers of MDROs, both to other patients and to themselves via collecting detailed longitudinal sampling and high-resolution typing. Lastly, to generate evidence for future policymaking for individualized antimicrobial decision rather than umbrella guidelines since the variance in the bacteriological profiles in different settings.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years old;
- •Inpatients;
- •Cirrhosis patients with acute decompensation;
排除标准
- •Patients decline any swab type;
- •Patients had liver resection or other organ transplantation;
- •Patients who had participated in, or are planning to participate in other clinical trial within the 3 months prior to enrollment;
- •Hospital stays <48 hours;
- •Not suitable to participate in this study judging by researchers;
结局指标
主要结局
The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers
时间窗: 90 days
The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers and describe the risk of colonization both to other patients and to themselves.
The prevalence of rectal colonization by MDROs in patients with cirrhosis
时间窗: 90 days
The prevalence of rectal colonization by MDROs in patients with cirrhosis during hospitalization
次要结局
- The risk factors associated with rectal colonization by MDROs in patients with cirrhosis.(90 days)