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.
調査の概要
状態
わからない
条件
詳細な説明
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.
研究の種類
観察的
入学 (予想される)
300
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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.
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Household contacts
This cohort are resident in the same household as the index patient (maximum of four).
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus.
時間枠：First household visit and swabbing of household contacts will be as soon as possible after recruitment of the index case.
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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.
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First household visit and swabbing of household contacts will be as soon as possible after recruitment of the index case.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Measure the frequency of Staphylococcus aureus transmission events within households over a three month period.
時間枠：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).
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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.
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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).
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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.
時間枠：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).
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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.
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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).
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Describe virulence characteristics of strains causing a) (invasive) infection and b) higher number of household transmission events
時間枠：Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.
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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.
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Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Thomas Darton、University of Sheffield
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年5月1日
一次修了 (予想される)
2021年7月1日
研究の完了 (予想される)
2021年9月1日
試験登録日
最初に提出
2021年3月3日
QC基準を満たした最初の提出物
2021年5月12日
最初の投稿 (実際)
2021年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2021年5月13日
QC基準を満たした最後の更新が送信されました
2021年5月12日
最終確認日
2021年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
黄色ブドウ球菌の臨床試験
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University Hospital, Basel, Switzerland募集複雑性黄色ブドウ球菌（S. aureus）感染症（CSAI）スイス