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临床试验/NCT05002582
NCT05002582Unknown不适用

Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs and the Relationship Between Colonization and Infection in Patients With Hematological Diseases in China

Sir Run Run Shaw Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
5,000
试验地点
1
主要终点
CRO intestinal colonization incidence

研究概览

简要总结

Carbapenem-resistant Organisms (CRO) include Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB). Due to the high fatality rate of CRO infection, and its potential for wide spread, it is currently one of the issues that seriously affect the global public health safety. In 2019, CDC of the United States listed CRE and CRAB as the highest level of "antibiotic-resistant bacteria with urgent threat", while CRPA was listed as "antibiotic-resistant bacteria with serious threat".

Previous studies show that in China, patients with hematological disease are at high-risk of CRE colonization and infection, but there still lack the data of colonization rate of CRPA and CRAB in patients with hematological disease. Intestinal flora is not only an important micro-ecological environment for the human body, but also an important place for the habitation of multidrug-resistant bacteria. The colonization of these bacteria can not only lead to the spread of bacteria in hospital, but also may lead to the translocation infection of carriers. Patients with hematological diseases are often in a state of neutropenia after chemotherapy. At the same time, chemotherapy drugs and various factors can cause intestinal mucosa damage, which is prone to induce intestinal microflora translocation, causing serious infections such as sepsis, and posing a serious threat to the prognosis of patients. Early detection of CRO carriers is not only beneficial to the control of nosocomial infection, but also beneficial to early precise anti-infection treatments, reducing the probability of infection and improving the prognosis of infected patients.

Our study is designed to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases, and the risk factors of intestinal CRO colonization in patients with hematological diseases and its correlation with subsequent infections. 5000 patients diagnosed with hematological diseases will be enrolled, and rectal swabs or feces will be collected to detect the CRE intestinal colonization. Subsequently, the last 6 months clinical data of CRO-colonized patients and matched non CRO-colonized patients (1:1) will be collected. Then, the randomly selected 200 CRO-colonized patients and matched 200 non CRO-colonized patients (1:1) are followed up for 12 months, a total of 400 patients will be enrolled. Every month, rectal swabs and relevant clinical data will be collected.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • On a certain day in each chosed hospital, all the inpatients diagnosed with hematological malignancies diseases will be enrolled

排除标准

  • Patients or their legal representatives refused to enter the study
  • Patients died because of hematological malignancies diseases.

结局指标

主要结局

CRO intestinal colonization incidence

时间窗: 1 year since enrollment

Positive culture any of these three organsisms: Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB)

次要结局

  • Bloodstream infection incidence(1 year after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian-cang Zhou M.D.

Professor

Sir Run Run Shaw Hospital

研究点 (1)

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