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

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.

Epidemiological review of confirmed Lassa fever cases during 2016-2018, in Plateau State, North Central Nigeria.

Lassa fever (LF) is endemic in West Africa and constitutes a significant public health concern due to its potential for epidemics and associated high mortality. The first reported case and management of Lassa fever in Plateau State occurred more than 50 years ago. We set out to undertake a three-year epidemiological review of LF cases in Plateau State, North Central Nigeria. This is a retrospective study of all confirmed LF cases in Plateau State between 2016 and 2018. Plateau state Lassa fever- Line list and patient case records were used to extract relevant data. Lassa PCR was carried out at the NCDC accredited Laboratory network. Data analysis was done using STATA version SE14.1. Forty-four persons (44) had confirmed LF over the examined period, 18 (41%) in 2016, 15 (34%) in 2017 and 11 (25%) in 2018. The mean age was 29.7±14.6 years and 53% were males. Sixty-six percent (66%) of the patients resided in rural areas. It affected all local government areas (LGA) in the state except Pankshin, Jos East and Kanke LGAs. Twenty-five percent (25%) of the cases occurred among underprivileged communities of Jos North and another 25% in rural dwellers of Langtang North. Fifty-nine percent (59%) of cases occurred during the 1st quarter, 27% the 2nd quarter and 18% the 3rd quarter of the year. The case fatality rate was 57%. LF is endemic in Plateau State. Prevention strategies must be sustained year round and target the youth, urban and rural underprivileged communities. There is also need for case management improvement to reduce mortality.