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

12 мая 2021 г. обновлено: 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.

Обзор исследования

Статус

Неизвестный

Условия

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

300

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
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).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus.
Временное ограничение: 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.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Measure the frequency of Staphylococcus aureus transmission events within households over a three month period.
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Sheffield

Соавторы

Rajarata University, Sri Lanka

Следователи

  • Главный следователь: Thomas Darton, University of Sheffield

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Ожидаемый)

1 мая 2021 г.

Первичное завершение (Ожидаемый)

1 июля 2021 г.

Завершение исследования (Ожидаемый)

1 сентября 2021 г.

Даты регистрации исследования

Первый отправленный

3 марта 2021 г.

Впервые представлено, что соответствует критериям контроля качества

12 мая 2021 г.

Первый опубликованный (Действительный)

13 мая 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

13 мая 2021 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

12 мая 2021 г.

Последняя проверка

1 марта 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • 164460

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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