A Prospective Cohort Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus.
研究概览
简要总结
This study will determine the frequency of Staphylococcus aureus carriage in household contacts of individuals with clinical infection due to this pathogen. It will also assess the frequency of transmission events over the following three months. Finally it will aim to identify predisposing characteristics both on a demographic/social level as well virulence characteristics of the identified strains.
详细描述
This is a prospective cohort study based at Anuradhapura Teaching Hospital (Sri Lanka). Potential index study participants will have clinical infection caused by Staphylococcus aureus and will be identified from hospital microbiology laboratory records within 48 hours of admission. With consent, the investigators will approach up to 4 household members for participation in the carriage study. With their consent, household members will have swabs collected on 2 occasions 3 months apart. All hospitalised patients will receive standard-of-care treatment in accordance with local practice and national guidance. Clinical, demographic and social/lifestyle data will be collected from index patients and households by scheduled interview performed by local investigators. Bacterial isolates from the initial index patient infection, and those identified through household member screening will be assessed for antimicrobial susceptibility, virulence factor repertoire and analysed by whole genome sequencing. While infection with the cc5 MRSA clone has been described in several hospital and hospital-associated settings in South Asia a major unresolved issue is whether transmission and circulation of this clone is occurring in community settings. In this study the investigators will investigate and characterise the household circulation of Staphylococcus aureus strains, exploring differences in bacterial virulence characteristics and host susceptibility factors associated with increased risk of carriage. Understanding these factors and estimating the burden of disease which may be occurring in the community setting will allow more accurate assessment of the risk posed by cc5 PVL-MRSA to similar Low and Middle Income Countries (LMIC) settings and signal potential routes to mitigation through treatment optimisation and disease prevention including infection control or vaccination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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
Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus.
时间窗: First household visit and swabbing of household contacts will be as soon as possible after recruitment of the index case.
Index cases will be identified by screening laboratory reports for samples obtained within 72 hours of hospital admission and where Staphylococcus aureus has been isolated from a skin or soft tissue infection or a normally sterile site and there is a clinical diagnosis of infection at that site. Up to 4 household contacts of this index case will be approached to participate in the study and will have bacterial swabs of the anterior nares and any incidental sites of infection at an initial assessment (as soon after identification and recruitment as possible). The swabs will be inoculated on to blood agar and MacConkey agar. Staphylococcus aureus will be identified by colonial morphology, Gram stain, catalase test and coagulase test. Methicillin resistant Staphylococcus aureus will be detected by disc diffusion method using a cefoxitin disc as per the CLSI protocol.
次要结局
- Characterise predisposing clinical, demographic or social characteristic differences of individuals/households with evidence of household transmission over a three month period by interview and completion of a proforma.(The baseline interviews will occur as soon as possible after the index patient is recruited and the second interview will occur three months later (window 2-4 months).)
- Describe virulence characteristics of strains causing a) (invasive) infection and b) higher number of household transmission events(Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.)
- Measure the frequency of Staphylococcus aureus transmission events within households over a three month period.(First visit and swabbing of the index and household contacts will be as soon as possible after recruitment of the index case. Both the index and household contacts will have a second visit 3 months later (window 2-4 months).)