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临床试验/NCT04085380
NCT04085380已完成不适用

Identification of New Highly Antibiotic-resistant Bacteria Carriage Risk Factors to Optimize the Detection and Medical Care for Carriers Patients

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 2,396 人开始时间: 2019年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,396
试验地点
1
主要终点
Risk factors

研究概览

简要总结

The aim of this study is to identify in hospitalized patients, the risk factors associated with the digestive colonisation by emergent extensively drug-resistant bacteria (eXDR), to optimize their detection and the medical care for carriers these patients

详细描述

CODBAHRE is a french, regional study, involving 9 centers. Recruitment will take place in all the departments of the centers involved under the supervision of the Infection Control Team.

All patients hospitalized more than 24 hours, on a given day are eligible for the protocol, except the patients unable to answer the questionnaire.

After collecting the non-opposition of the patient, patients will be screened by rectal swab and a questionnaire will be completed.

Each sample will be analyzed to detect eXDR carrying patients.

The carrying patients will be followed during 6 months to estimate the proportion of the population which developped a bacterial infection. This information will be collected by a retrospective telephone survey of carrying patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Hospitalization of more than 24 hours
  • Give his no objection

排除标准

  • Hospitalization in psychiatry
  • Unwilling to participate

结局指标

主要结局

Risk factors

时间窗: at inclusion

Identification of risk factors for digestive colonisation by highly resistant bacteria Lifestyle questionnaire: environment, diet, medical history and result of the rectal swab

次要结局

  • Proportion of patients carrying "eXDR" who will develop an infection with the same germ referred to the number of eXDR carriers(6 months)
  • Prevalence of co-carrying patients of eXDR and ESBL will be determined by the number of patients who carrying eXDR and ESBL referred to the number of patients sampled(1 day)
  • Cross-transmission rate of eXDR(1 day)
  • Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).(16 months)
  • Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic(16 months)
  • Prevalence of multidrug-resistant bacteria will be determined by the number of patients who have been detected at least one multidrug-resistant bacteria referred to the number of patients sampled(1 day)
  • Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).(16 months)
  • Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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