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A Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka

2021年5月12日更新者：University of Sheffield

A Prospective Cohort Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka

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.

研究概览

地位

未知

条件

金黄色葡萄球菌

详细说明

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.

研究类型

观察性的

注册 (预期的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The index patients will have clinical infection due to Staphylococcus aureus identified during admission to Anuradhapura General Hospital.

The household contacts will be resident in the same household as the index patient so will be part of the local community served by Anuradhapura General Hospital.

描述

Inclusion Criteria (index patient):

Confirmed clinical infection caused by Staphylococcus aureus infection, including skin and soft tissue infection (SSTI) or infection of a normally sterile site.
Participant is willing and able to give informed consent for participation in the study.
Male or Female greater or equal to 18 years old.
Household is within one day's travel of the Hospital.

Inclusion Criteria (household contact):

Resident in the same household as index participant.
Participant is willing and able to give informed consent for participation in the study if greater or equal to 18 years old or the parent/legal guardian if participant is less than 18 years old.
Likely continued household residence for at least 3 months from initial sample collection.
Able to comply with study requirements.

Exclusion Criteria (index patient):

- Deemed unsuitable by the responsible clinical team/clinician (e.g. terminal illness).

Exclusion Criteria (household contact):

Not a resident of the household at the time of the index patient hospital admission.
Deemed unsuitable by the responsible clinical team/clinician (e.g. terminal illness)
At least 4 household contacts already enrolled to this study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Index patient Adults with confirmed clinical infection caused by Staphylococcus aureus, including skin and soft tissue infection or infection of a normally sterile site. These cases will be identified following admission to Anuradhapura General Hospital.
Household contacts This cohort are resident in the same household as the index patient (maximum of four).

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus. 大体时间：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.	First household visit and swabbing of household contacts will be as soon as possible after recruitment of the index case.

次要结果测量

结果测量	措施说明	大体时间
Measure the frequency of Staphylococcus aureus transmission events within households over a three month period. 大体时间：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).	Proportion of household individuals carrying same/similar strains, as determined by similarity in antimicrobial susceptibility profile and genotypic homology. This will be assessed over a three month time period to detect possible household transmission in contacts who are initially not detected as carriers.	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).
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. 大体时间：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).	After consent is obtained, study investigators will visit the dwellings to assess up to 4 household contacts. A baseline interview using a proforma will be conducted to investigate each individual and their shared dwellings. This will include identification of: dwelling location, type of dwelling, number of other inhabitants, pet/animal ownership, occupations, duration of residence, recent illness/hospitalisations, recent courses of antimicrobial treatment. This will be repeated at the follow up visit to ensure there have not been any change in circumstances.	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 大体时间：Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.	Analysis of whole genome sequencing and antimicrobial virulence data from isolates that are more associated with infection (in the index and household contacts) and where a high frequency of household transmission has been observed.	Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Sheffield

合作者

Rajarata University, Sri Lanka

调查人员

首席研究员：Thomas Darton、University of Sheffield

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年5月1日

初级完成 (预期的)

2021年7月1日

研究完成 (预期的)

2021年9月1日

研究注册日期

首次提交

2021年3月3日

首先提交符合 QC 标准的

2021年5月12日

首次发布 (实际的)

2021年5月13日

研究记录更新

最后更新发布 (实际的)