Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE) (CODBAHRE)
Identification of New Highly Antibiotic-resistant Bacteria Carriage Risk Factors to Optimize the Detection and Medical Care for Carriers Patients
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
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Paris、法国
- HEGP
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Hospitalization of more than 24 hours
- Give his no objection
Exclusion Criteria:
- Hospitalization in psychiatry
- Unwilling to participate
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Risk factors
大体时间：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
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at inclusion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间：1 day
|
Number of patient carrying a Multidrug-resistant bacteria in Ile de France
|
1 day
|
|
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
大体时间：1 day
|
Estimate the prevalence of "co-carrying patients of eXDR and ESBL in the Ile de France
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1 day
|
|
Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled
大体时间：1 day
|
Establish whether there are significant differences between hospital associated with the recruitment of these institutions.
|
1 day
|
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Proportion of patients carrying "eXDR" who will develop an infection with the same germ referred to the number of eXDR carriers
大体时间：6 months
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Estimate the proportion of patients colonized by a "eXDR" who will develop an infection with the same germ.
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6 months
|
|
Cross-transmission rate of eXDR
大体时间：1 day
|
Number of cross transmissions during the study by comparing the eXDR bacteria genotypes in the same unit
|
1 day
|
|
Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).
大体时间：16 months
|
Identify possible links between strains
|
16 months
|
|
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).
大体时间：16 months
|
Characterize the resistance and virulence factors of certain strains.
|
16 months
|
|
Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic
大体时间：16 months
|
Comparison culture vs molecular biology technics.
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16 months
|
合作者和调查者
调查人员
- 首席研究员：Najiby Kassis-Chikhani, PhD、AP-HP, Hôpital Européen Georges Pompidou, Paris
- 首席研究员：Jean-Ralph Zahar, PhD、AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, Bobigny
- 首席研究员：Véronique Moulin、AP-HP, Hôpital Corentin Celton, et Vaugirard
- 首席研究员：Pierre Frange, PhD、AP-HP, Hôpital Necker enfants malades, Paris
- 首席研究员：Christine Lawrence, PhD、AP-HP, Hôpital Raymond Poincaré, Garches
- 首席研究员：Frédéric Barbut, PhD、AP-HP-Hôpital Saint Antoine, Paris
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CODBAHRE
- APHP180561 (其他标识符：AP-HP)
- 2019-A01226-51 (其他标识符：IDRCB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 共享时间框架
IPD 共享访问标准
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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