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临床试验/CTRI/2022/11/047361
CTRI/2022/11/047361尚未招募不适用

Global Action in Healthcare Network (GAIHN) - Antimicrobial Resistance, India, Enhanced infection control and prevention driven by targeted surveillance

US Centers for Disease Control and Prevention5 个研究点 分布在 1 个国家目标入组 9,600 人开始时间: 2023年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
9,600
试验地点
5
主要终点
CRO, CP-CRO, and CR-CRO per 1,000 patient days.

研究概览

简要总结

Purpose of the study is to implement a program of enhanced infection control and prevention guided by active and passive surveillance for carbapenem and colistin resistant Gram-negative organism.

研究设计

研究类型
Observational

入排标准

年龄范围
12.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Component 1 (passive surveillance) Passive surveillance will occur for cultures sent from designated wards.
  • All GN isolates found to be CRO by local standard of care AST may be included.
  • Component 2 (active surveillance) Patients will be considered for inclusion in active surveillance who are identified as part of a contact investigation for an index case of a critical CRO or possible nosocomial transmission event or are admitted to a ward designated for universal active surveillance.
  • Component 3 (case investigation):Patients who have an isolate that is a critical CRO (rare or novel resistance mechanism or resistance to treatment) or identified as being part of possible nosocomial transmission will be included.
  • Inpatient contacts identified through case investigation will be included.
  • Component 4 (enhanced IPC) Individual patients will not be included in enhanced IPC.
  • Wards selected for enhanced IPC will include ICUs and wards where critical CRO detection or nosocomial transmission is occurring.

排除标准

  • Exclusion Criteria • Species not considered to be of concern for IPC activities • Age < 12 years • Patient declines to participate in study activities.

结局指标

主要结局

CRO, CP-CRO, and CR-CRO per 1,000 patient days.

时间窗: six monthly

prevalence of CRO, CP-CRO, and CR-CRO colonization at admission.

时间窗: six monthly

Changes in thefrequency of CRO, CP-CRO, and CR-CRO

时间窗: six monthly

次要结局

  • Change in technical capacity in bacteriology laboratories to detect and characterize CRO, CP-CRO, and CR-CRO(Baseline and endline)

研究者

发起方
US Centers for Disease Control and Prevention
申办方类型
Government funding agency

研究点 (5)

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