A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever.

Autor: Olayinka AT; Nigeria Centre for Disease Control, Abuja, Nigeria., Bourner J; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom., Akpede GO; Irrua Specialist Teaching Hospital, Irrua, Edo, Nigeria., Okoeguale J; Irrua Specialist Teaching Hospital, Irrua, Edo, Nigeria., Abejegah C; Federal Medical Center, Owo, Ondo State, Nigeria., Ajayi NA; Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria., Akude C; Bingham University Teaching Hospital, Jos, Nigeria., Ayodeji O; Federal Medical Center, Owo, Ondo State, Nigeria., Bausch DG; UK Public Health Rapid Support Team, Public Health England, London, United Kingdom.; London School of Hygiene & Tropical Medicine, London, United Kingdom., de Clerck H; Médecins sans Frontières, Brussels, Belgium., Dan-Nwafor C; Nigeria Centre for Disease Control, Abuja, Nigeria., Dunning J; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.; National Infection Service, Public Health England, London, United Kingdom., Erameh C; Irrua Specialist Teaching Hospital, Irrua, Edo, Nigeria., Eze JN; Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria., Formenty P; World Health Organisation, Geneva, Switzerland., Gillesen A; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom., Jalloh S; Ola During Children's Hospital, Freetown, Sierra Leone., Jaspard M; The Alliance for International Medical Action (ALIMA), Dakar, Senegal.; Institut Nationale de la Santé et de la Recherche Medicale (Inserm), Infectious Diseases in Low Income Contries, Unit 1219, Bordeaux, France., Jegede T; Federal Medical Center, Owo, Ondo State, Nigeria., Maikere J; Médecins sans Frontières, Brussels, Belgium., Malvy D; The Alliance for International Medical Action (ALIMA), Dakar, Senegal.; Institut Nationale de la Santé et de la Recherche Medicale (Inserm), Infectious Diseases in Low Income Contries, Unit 1219, Bordeaux, France., Ogbaini-Emovon E; Irrua Specialist Teaching Hospital, Irrua, Edo, Nigeria., Ojo OE; Federal Medical Center, Owo, Ondo State, Nigeria., Okogbenin S; Irrua Specialist Teaching Hospital, Irrua, Edo, Nigeria., O'Neill K; Ministry of Health and Sanitation, Freetown, Sierra Leone., Orji ML; Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria., Owhin SO; Federal Medical Center, Owo, Ondo State, Nigeria., Ramharter M; Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.; Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Samuels RJ; Kenema Government Hospital, Kenema, Sierra Leone., Shehu N; Jos University Teaching Hospital, Jos, Plateau State, Nigeria., Merson L; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom., Salam AP; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom., Kayem ND; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom., Horby P; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom., Ihekweazu C; Nigeria Centre for Disease Control, Abuja, Nigeria., Olliaro P; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Jazyk: angličtina
Zdroj: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2022 Jan 06; Vol. 16 (1), pp. e0010089. Date of Electronic Publication: 2022 Jan 06 (Print Publication: 2022).
DOI: 10.1371/journal.pntd.0010089
Abstrakt: Background: Only one recommendation currently exists for the treatment of Lassa fever (LF), which is ribavirin administered in conjunction with supportive care. This recommendation is primarily based on evidence generated from a single clinical trial that was conducted more than 30 years ago-the methodology and results of which have recently come under scrutiny. The requirement for novel therapeutics and reassessment of ribavirin is therefore urgent. However, a significant amount of work now needs to be undertaken to ensure that future trials for LF can be conducted consistently and reliably to facilitate the efficient generation of evidence.
Methodology: We convened a consultation group to establish the position of clinicians and researchers on the core components of future trials. A Core Eligibility Criteria (CEC), Core Case Definition (CCD), Core Outcome Set (COS) and Core Data Variables (CDV) were developed through the process of a multi-stakeholder consultation that took place using a modified-Delphi methodology.
Results: A consensus position was achieved for each aspect of the framework, which accounts for the inclusion of pregnant women and children in future LF clinical trials. The framework consists of 8 core criteria, as well as additional considerations for trial protocols.
Conclusions: This project represents the first step towards delineating the clinical development pathway for new Lassa fever therapeutics, following a period of 40 years without advancement. Future planned projects will bolster the work initiated here to continue the advancement of LF clinical research through a regionally-centred, collaborative methodology, with the aim of delineating a clear pathway through which LF clinical trials can progress efficiently and ensure sustainable investments are made in research capacity at a regional level.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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