The Potential Role of the Household Environment as the Reservoir for Invasive Salmonellosis in Children, Kisangani, DR Congo.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Environmental presence of NTS in household of index patients
研究概览
简要总结
Bloodstream infections caused by non-typhoid Salmonella (NTS) are a major killing disease in Sub-Saharan Africa. Despite the high case fatality rate, the main reservoir -human, zoonotic or environmental- for invasive NTS rests unknown.
The main objective of this study is to assess
- the household environment (household member, cattle and pets, rats) for intestinal carriage of NTS and
- the household water supply for presence of NTS .
Households of children with proven NTS invasive infection will be addressed.
详细描述
This study will be a case-based microbiological assessment of the household environment of index patients presenting with NTS infection. Index patients with laboratory confirmed NTS bloodstream infections will be randomly addressed for the collection of samples from their household (household members, animals (domestic animals and rats) and water supply). The collection of those samples will be done as close as possible to the timing of diagnosis in the index patient.
The sites of blood culture collection are the General Hospitals of Makiso and Kabondo and the Centre Hospitalier Village de Pédiatrie. Blood cultures will be drawn by nursing staff according to the standard procedures of the surveillance study. A total of 1500 blood cultures is expected with a positivity rate of 10% (Falay, 2016). According to previous prevalence data in DR Congo, the expected number of NTS in this sample group will be 50 isolates.
The isolates of Salmonella sp. conserved on TSA agar will be shipped to ITM and the molecular identity of the isolates will be determined and pairs of isolates (index patient-household environment) will be compared for clonal identity, by whole genome sequencing or equivalent technique as appropriate.
A database will be completed that contains the study data. Data that can have a link to the patient identity will be coded.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Households where at least one child is diagnosed with NTS bloodstream infection
- •Willing to give informed consent
排除标准
- •Refusal of participation
结局指标
主要结局
Environmental presence of NTS in household of index patients
时间窗: 3 months
Stool samples of rats,animals and household members as well as samples from household water sources will be collected to assess the presence of Salmonella spp.
Genetic relatedness of environmental/household and index patient results
时间窗: 3 months
Assessment of genetic relatedness/clonal identity of Salmonella isolates of index patients, household members and the household environment through whole genome sequencing or equivalent techniques.
次要结局
- Targeted control prevention measures for blood stream infections caused by NTS in DR Congo by training provided by health personnel(3 months)
- Potential demonstration of common source of Salmonella infections in the community by sampling of household environment for NTS, guided by the answers given to questionnaires(3 months)
- Public health knowledge for blood stream infections caused by NTS in DR Congo(3 months)