布路里溃疡人体模型：溃疡分枝杆菌控制性人体感染研究临时方案。

Q1 Medicine

Wellcome Open Research Pub Date : 2024-10-21 eCollection Date: 2024-01-01 DOI:10.12688/wellcomeopenres.22719.1

Stephen Muhi, Julia L Marshall, Daniel P O'Brien, Paul D R Johnson, Gayle Ross, Anand Ramakrishnan, Laura K Mackay, Marcel Doerflinger, James S McCarthy, Euzebiusz Jamrozik, Joshua Osowicki, Timothy P Stinear

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引用次数: 0

摘要

溃疡分枝杆菌是被忽视的热带疾病布路里溃疡（BU）的病原体，严重的知识差距阻碍了在减轻溃疡分枝杆菌造成的全球疾病负担方面取得进展。有人建议开发布路里溃疡的受控人类感染模型，作为探索宿主与病原体相互作用以及评估预防、诊断和治疗工具的实验平台。我们之前介绍了新人类模型的使用案例，并确定溃疡曼氏菌 JKD8049 为合适的挑战菌株。在此，我们提出了一项初步研究的临时方案，以便在方案制定的最初阶段进行透明的同行评审。在对该临时方案进行科学同行评审和社区/利益相关者咨询的同时，我们将提交一份完善的方案供机构审查委员会（IRB）评估。

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A human model of Buruli ulcer: Provisional protocol for a Mycobacterium ulcerans controlled human infection study.

Critical knowledge gaps have impeded progress towards reducing the global burden of disease due to Mycobacterium ulcerans, the cause of the neglected tropical disease Buruli ulcer (BU). Development of a controlled human infection model of BU has been proposed as an experimental platform to explore host-pathogen interactions and evaluate tools for prevention, diagnosis, and treatment. We have previously introduced the use case for a new human model and identified M. ulcerans JKD8049 as a suitable challenge strain. Here, we present a provisional protocol for an initial study, for transparent peer review during the earliest stages of protocol development. Following simultaneous scientific peer review and community/stakeholder consultation of this provisional protocol, we aim to present a refined protocol for institutional review board (IRB) evaluation.

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来源期刊

Wellcome Open Research Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)

CiteScore

5.50

自引率

0.00%

发文量

426

审稿时长

1 weeks

期刊介绍： Wellcome Open Research publishes scholarly articles reporting any basic scientific, translational and clinical research that has been funded (or co-funded) by Wellcome. Each publication must have at least one author who has been, or still is, a recipient of a Wellcome grant. Articles must be original (not duplications). All research, including clinical trials, systematic reviews, software tools, method articles, and many others, is welcome and will be published irrespective of the perceived level of interest or novelty; confirmatory and negative results, as well as null studies are all suitable. See the full list of article types here. All articles are published using a fully transparent, author-driven model: the authors are solely responsible for the content of their article. Invited peer review takes place openly after publication, and the authors play a crucial role in ensuring that the article is peer-reviewed by independent experts in a timely manner. Articles that pass peer review will be indexed in PubMed and elsewhere. Wellcome Open Research is an Open Research platform: all articles are published open access; the publishing and peer-review processes are fully transparent; and authors are asked to include detailed descriptions of methods and to provide full and easy access to source data underlying the results to improve reproducibility.