Household Transmission Dynamics of Multidrug Resistant Enterobacterales
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 507
- 试验地点
- 1
- 主要终点
- Secondary attack rate (SAR) for confirmed transmissions, i.e. the proportion of confirmed acquisitions of MDR-E (based on genetic analysis of strains) in all household members over the study period
研究概览
简要总结
The HOME study will prospectively follow a cohort of Multi-Drug Resistant Enterobacterales (MDR-E) carriers after hospital discharge, and their related household members over a 3-month period. The main objective is to estimate the rate of confirmed transmissions of MDR-E from the index cases to related household members, and identify predictors associated with transmission. Transmission will be confirmed by comparing genomic analysis of the MDR-E strains isolated both in the index patient and his/her household members, based on the number of Single nucleotide polymorphisms (SNPs) differences between nearby genomes by Variant Calling. Multifactorial processes involved in MDR-E transmission in households will be explored with stochastic individual-based modelling. The parameterized model will be used to simulate and assess different strategies of control of MDR-E emergence and transmission to households. The impact of modifying patterns of human-contacts, promote hygiene and control barriers (decontamination of objects or surfaces, variations in antibiotic use, reinforcement of hand hygiene) will be assessed.
详细描述
Multi-Drug Resistant Enterobacterales (MDR-E), i.e. Extended-Spectrum Beta-Lactamase producing Enterobacterales (ESBL-E) and Carbapenemase-Producing Enterobacterales (CPE) are spreading worldwide. Although initially considered a healthcare-associated problem, reports of ESBL-E carriage and infections in individuals without any previous exposure to health care raise concerns on their alarming dissemination in the community. Very few reports investigated the dynamics of transmission of MDR-E from carriers to household members. Risk factors of acquisition (related to the strain, household habits, travel, occupational activities...) were poorly assessed.
Quantifying and understanding the mechanisms of household transmission is of major importance to elaborate control strategies specifically designed to the community.
The main objective is to estimate the rate of confirmed transmissions of MDR-E from an index case to related household members.
The primary endpoint is defined by the secondary attack rate (SAR) for confirmed transmissions, i.e. the proportion of confirmed (based on genetic analysis of strains) acquisitions of MDR-E in all household members over the study period (three months).
Screening of eligible patients will rely on an automated daily request of all MDR-E positive samples that is already implemented in the participating centers.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Secondary attack rate (SAR) for confirmed transmissions, i.e. the proportion of confirmed acquisitions of MDR-E (based on genetic analysis of strains) in all household members over the study period
时间窗: 3 months
次要结局
- Bray-Curtis unweighted UniFrac distance in pairs index/household member with or without confirmed transmission(3 months)
- Bray-Curtis dissimilarity in pairs index/household member with or without confirmed transmission(3 months)
- Hazard ratios of epidemiological and microbiological factors associated with decolonization(3 months)
- SAR for possible transmissions, i.e. the proportion of possible (based on phenotypic analysis of strains) acquisitions of MDR-E in all household members over the study period(3 months)
- Duration of interactions between index and household participants(4 days)
- Number of observed Operational Taxonomic Units in pairs index/household member with or without confirmed transmission(3 months)
- Hazard ratios of epidemiological and microbiological factors associated with confirmed transmission(3 months)
- Median time to decolonization in MDR-E carriers (index or household members)(3 months)
- Diversity indices of the microbiota (Shannon diversity index) in pairs index/household member with or without confirmed transmission(3 months)
- Number of interactions between index patients and household participants(4 days)