Lassa fever clinical course and setting a standard of care for future randomized trials: A protocol for a cohort study of Lassa-infected patients in Nigeria (LASCOPE).,Travel Medicine and Infectious Disease

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Lassa fever clinical course and setting a standard of care for future randomized trials: A protocol for a cohort study of Lassa-infected patients in Nigeria (LASCOPE).
Travel Medicine and Infectious Disease ( IF 12.0 ) Pub Date : 2020-01-21 , DOI: 10.1016/j.tmaid.2020.101557
Alexandre Duvignaud ₁ , Marie Jaspard ₂ , Ijeoma Chukwudumebi Etafo ₃ , Béatrice Serra ₂ , Chukwuyem Abejegah ₃ , Delphine Gabillard ₄ , Mahamadou Doutchi ₅ , Josephine Funmilola Alabi ₃ , Moses Adeniyi Adedokun ₃ , Adewale Oladayo Akinpelu ₃ , Oyebimpe Ope Oyegunle ₃ , Johnson Etafo ₆ , Ayoleyi Omowunmi Dede ₆ , Macdonald Nonso Onyechi ₆ , Moronke Uzuajemeh Ireneh ₆ , Olufunke Gbenga-Ayeni ₆ , Kehinde Gbemisola Fadiminiyi ₆ , Patience Iziegbe Ehigbor ₆ , Eric Ouattara ₄ , Claire Levy-Marchal ₇ , Sophie Karcher ₄ , Larissa N'guessan-Koffi ₄ , Irmine Ahyi ₄ , Elvis Amani ₄ , Mamoudou Diabaté ₄ , Bertine Siloué ₄ , Justine Schaeffer ₇ , Augustin Augier ₇ , Ephraim Ogbaini-Emovon ₈ , Alex Paddy Salam ₉ , Peter Horby ₉ , Liasu Adeagbo Ahmed ₁₀ , Stephan Günther ₁₁ , Akinola Nelson Adedosu ₆ , Xavier Anglaret ₄ , Oladele Oluwafemi Ayodeji ₃ , Denis Malvy ₁

Affiliation

Inserm U1219, University of Bordeaux, 146 Rue Léo Saignat, 33076, Bordeaux, France; Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, CHU de Bordeaux, Hôpital Pellegrin, Place Amélie Raba Léon, 33076, Bordeaux, France; Programme PAC-CI/ANRS Research Site, CHU de Treichville, 18 BP 1954 Abidjan 18, Abidjan, Côte d'Ivoire.
Inserm U1219, University of Bordeaux, 146 Rue Léo Saignat, 33076, Bordeaux, France; Programme PAC-CI/ANRS Research Site, CHU de Treichville, 18 BP 1954 Abidjan 18, Abidjan, Côte d'Ivoire; The Alliance for International Medical Action, Route de l'Aéroport, Rue NG 96 BP: 15530, Dakar, Senegal.
Lassa Fever Response Team, Infection Control and Research Centre, Federal Medical Centre Owo, Michael Adekun Ajasin Road, PMB 1053, Owo, Ondo State, Nigeria.
Inserm U1219, University of Bordeaux, 146 Rue Léo Saignat, 33076, Bordeaux, France; Programme PAC-CI/ANRS Research Site, CHU de Treichville, 18 BP 1954 Abidjan 18, Abidjan, Côte d'Ivoire.
The Alliance for International Medical Action, Route de l'Aéroport, Rue NG 96 BP: 15530, Dakar, Senegal; Department of Infectious Diseases, Centre Hospitalier National de Zinder, Zinder, Niger.
Viral Hemorrhagic Fever Laboratory, Infection Control and Research Centre, Federal Medical Centre Owo, Michael Adekun Ajasin Road, PMB 1053, Owo, Ondo State, Nigeria.
The Alliance for International Medical Action, Route de l'Aéroport, Rue NG 96 BP: 15530, Dakar, Senegal.
Institute of Lassa Fever Research and Control, Irrua Specialist Teaching Hospital, KM 87 Benin Auchi Rd, Irrua, Edo State, Nigeria.
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Old Road Campus, Roosevelt Drive, Headington, Oxford, OX3 7FZ, United Kingdom.
Department of Family Medicine, Owo Federal Medical Centre, Michael Adekun Ajasin Road, PMB, 1053, Owo, Ondo State, Nigeria.
Department of Virology, Bernhard Nocht Institute for Tropical Medicine, Bernhard-Nocht-Straße 74, 20359, Hamburg, Germany.

Background

Lassa Fever (LF), is a severe viral disease prevalent in Western Africa. It is classified as a priority disease by the World Health Organization (WHO). Ribavirin is the recommended therapy despite weak evidence of its efficacy. Promising therapeutic agents are becoming available for evaluation in human. Before launching therapeutic trials, we need data on the evolution of the disease under the best possible conditions of care.

Methods

We have initiated a prospective study in Nigeria to better understand the clinical course and prognostic factors of LF while implementing high quality standardized care. Inclusion criteria are: suspected or confirmed LF and informed consent. Participants are followed 60 days from admission and receive free of charge standardized supportive care and biological monitoring, as well as intravenous ribavirin for those with confirmed LF. Data are collected using standardized case report forms (CRF). Primary and secondary outcomes are fatality and severe morbidity, with special focus on acute kidney dysfunction and pregnancy complications. Factors associated with outcomes will be investigated.

Results

The cohort is planned for 3 years. Inclusions started in April 2018 at the Federal Medical Center Owo in Ondo State. A second site will open in Nigeria in 2020 and discussions are underway to open a site in Benin. 150 to 200 new participants are expected per year.

Conclusions

This cohort will: provide evidence to standardize LF case management; provide key inputs to design future clinical trials of novel therapeutics; and establish clinical research teams capable of conducting such trials in LF-endemic areas.

Study registration

The LASCOPE study was registered on ClinicalTrial.gov (NCT03655561).

中文翻译：

拉沙热临床病程和为未来随机试验设定护理标准：尼日利亚拉沙热患者队列研究方案 (LASCOPE)。

背景

拉沙热 (LF) 是一种严重的病毒性疾病，流行于西非。它被世界卫生组织（WHO）列为重点疾病。利巴韦林是推荐的治疗方法，尽管其疗效的证据不足。有前景的治疗剂可用于人体评估。在启动治疗试验之前，我们需要在可能的最佳护理条件下疾病演变的数据。

方法

我们在尼日利亚启动了一项前瞻性研究，以在实施高质量标准化护理的同时更好地了解 LF 的临床过程和预后因素。纳入标准为：疑似或确诊 LF 和知情同意。参与者在入院后 60 天接受随访，并接受免费的标准化支持性护理和生物监测，以及为确诊为 LF 的患者静脉注射利巴韦林。使用标准化病例报告表 (CRF) 收集数据。主要和次要结果是死亡率和严重发病率，特别关注急性肾功能障碍和妊娠并发症。将调查与结果相关的因素。