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The Design and Development of a Multicentric Protocol to Investigate the Impact of Adjunctive Doxycycline on the Management of Peripheral Lymphoedema Caused by Lymphatic Filariasis and Podoconiosis

Kybernetika(2020)SCI 4区

Tropical Projects

Cited 19|Views38
Abstract
As new lymphatic filariasis infections are eliminated through mass chemotherapy, previously affected individuals are left with the sequellae, especially chronic progressive lymphoedema. Currently this is managed by careful attention to limb hygiene to prevent infection. Studies over the past 15 years have suggested that the incorporation of doxycycline treatment may arrest or even reverse progression of lymphoedema. Most of this work has been observational or based on small studies, and if this intervention is effective, studies need to be conducted on a larger scale and under diverse geographical and social conditions before it can be incorporated into treatment policy. The double-blind, placebo-controlled study was designed to investigate the impact of six weeks treatment with doxycycline added to standard limb hygiene on early stage filarial lymphoedema in five sites in Africa and the Indian subcontinent. One site in Cameroon is selected for studying lymphoedema in podoconiosis. Each site was individually powered with the potential to undertake a meta-analysis on completion. Evaluation methods followed those used in Ghana in 2012 with additions resulting from advances in technology. The details of the core protocol and how it was varied to take account of differing situations at each of the sites are provided. The study will enrol up to 1800 patients and will complete in mid-2021. This paper provides details of what challenges were faced during its development and discusses the issues and how they were resolved. In particular, the reasons for inclusion of new technology and the problems encountered with the supply of drugs for the studies are described in detail. By making these details available, it is hoped that the study protocol will help others interested in improving treatment for filarial lymphoedema in the design of future studies. Trial registration India: Clintrials.gov. NCT02929121 registered 10 Oct 2016: https://clinicaltrials.gov/ct2/show/NCT02929121 Mali: Clintrials.gov. NCT02927496 registered 7 Oct 2016: https://clinicaltrials.gov/ct2/show/NCT0292749 Sri Lanka: Clintrials.gov. NCT02929134 registered 10 Oct 2016: https://clinicaltrials.gov/ct2/show/NCT02929134 Ghana: ISRCTN. 14042737 registered 10 July 2017: https://doi.org/10.1186/ISRCTN14042737 Tanzania: ISRCTN. 65756724 registered 21 July 2017: https://doi.org/10.1186/ISRCTN65756724 Cameroon: ISRCTN. 1181662 registered 25 July 2017: https://doi.org/10.1186/ISRCTN11881662
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Key words
Lymphatic filariasis,Podoconiosis,Doxycycline,Hygiene,Lymphoedema,Clinical trial,Morbidity management
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要点】:本文介绍了针对淋巴丝虫病和 podoconiosis 引起的周围淋巴水肿的六周多西环素辅助治疗的多中心协议设计,旨在探讨其在标准肢体卫生护理中的影响。创新点在于通过新技术的应用和跨地理、社会条件的多样性研究,为淋巴丝虫病淋巴水肿的治疗提供实验依据。

方法】:采用双盲、安慰剂对照试验,对非洲和印度次大陆五个地点的早期丝虫病淋巴水肿进行研究,其中在喀麦隆的一个地点研究podoconiosis引起的淋巴水肿。每个地点独立进行,具备进行完成后Meta分析的潜力。

实验】:研究最多招募1800名患者,预计2021年中完成。使用2012年加纳使用的评估方法,并根据每个地点的不同情况对核心协议进行调整。数据集名称分别为:印度NCT02929121、马里NCT02927496、斯里兰卡NCT02929134、加纳ISRCTN14042737、坦桑尼亚ISRCTN65756724和喀麦隆ISRCTN1181662。