Interventions to Decrease Carbapenem Resistant Enterobacteriaceae Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater
研究概览
简要总结
Carbapenem resistant Enterobacteriaceae (CRE) colonization of patients discharged from hospitals is a source of transmission to the community. In a cluster randomized controlled trial the effect of a bundle of interventions will be assessed on CRE transmission from CRE+ index patient discharged from hospital to HouseHold (HH) members. The districts in two provinces will be randomized to intervention or control. An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic (AB) use. The effect will be evaluated on CRE transmission between HH members, livestock and environment through consecutive CRE screening using fecal and hospital effluent samples cultured on carbapenem selective media. Knowledge, Attitudes, Practice surveys with smartphones will assess health seeking, AB use and hygiene adherence, hence detecting the effect of interventions. If transmission of CRE +/- Colistin Resistant Enterobacteriaceae (CoRE, common among livestocks) is detected the source will be investigated including livestock and food, targeted information will be given and evaluated. In hospitals the effect of cohort care will be assessed on CRE acquisition, hospital acquired infection, treatment outcome, costeffectiveness and contamination in sewage water. Mechanisms of resistance, relatedness of CRE isolates in different One Health departments, and rate of CRE transmission from humans to animals and vice versa, will be assessed through Whole Genome Sequencing (WGS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients under 2 years old at the selected hospital are highly appreciated to join the study.
排除标准
- •Patients not from the selected hospital and individuals outside the selected province
结局指标
主要结局
Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater
时间窗: 24 months from the starting of the project
The CRE isolated from rectal swab of patient admitted to hospital, household members, animals and wastewater will be subjected to Whole Genome Sequencing using Oxford MinION Nanopore/Illumina Miseq sequencing and bioinformatics analysis to investigate the mechanisms of resistance in different One-Health compartments.
Cheng th prevalence of CRE transmission in the household
时间窗: 12 months from the starting of recruitment community participants
The Household Education Communication Hygiene Intervention expected to reduce the transmission of CRE from index patient to household member.
Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community
时间窗: 24 months from the starting of the project
The presence of CRE in hospital wastewater before and after treatment will be compared to evaluate the effectiveness of the treatment system on preventing the spreading of AMR to the community.
Change the prevalence of CRE colonisation
时间窗: 12 months from the starting of recruitment patients
The intervention at hospital will lead to the reduction of CRE colonisation, hospital acquire infection, treatment duration and costs.
Change the awareness regarding AMR of local people
时间窗: 18 months from the starting of recruitment community participants
The understanding on AMR, particularly of CRE, proper use of antibiotic for both humans and animals, will be improved. This will be measured through the quantitative questionnaires.
次要结局
未报告次要终点
研究者
Pham-Duc Phuc
Deputy Director of Center for Public Health and Ecosystem Research
Hanoi University of Public Health