CORDIS - EU research results

The Integrate study : An adaptive platform trial for the development of a new intervention to combat Lassa fever in Africa

Project description

Improving Lassa fever control in Nigeria

Lassa fever (LF) is a severe illness with a high mortality rate among hospitalised patients in West Africa. Currently, there is no secure and efficient treatment for LF, with the exception of ribavirin, which some experts question. The implementation of an effective treatment would reduce mortality rates and alleviate socioeconomic implications. Nigeria bears the highest burden of LF, accounting for 80 % of global cases. The EU-funded INTEGRATE project seeks to establish a clinical trial platform to evaluate both repurposed and new drugs in Nigeria and other affected countries. By facilitating technology transfer and training, both between north and south and among different countries in the south, the project aims to enhance the capacity of sites, laboratories and medical care facilities.


Lassa fever (LF) is an acute febrile illness associated with bleeding, organ failure, and shock caused by Lassa virus. LF causes outbreaks in West African with in-hospital mortality up to 12%. Challenges in the clinical care of patients are multiple due to the limited availability of LF molecular diagnostics, the risk for nosocomial transmission, and the limited treatment options.There are currently no safe and effective treatment options available for LF, except ribavirin, the efficacy of which is debated. The clinical development and accessibility of effective treatment options would be a game-changer towards reducing mortality associated with this disease and limiting its socio-economic impact. Nigeria is the country by far most affected by LF in the world with about 80% of global cases.
The INTEGRATE consortium builds on a more than 15 years lasting highly successful collaboration between leading European and West African institutions focusing on the joint priority to better understand, manage, and combat LF in West Africa.
The overall objective of the INTEGRATE project is to establish a GCP-compliant adaptive clinical platform trial in West Africa (Nigeria and other countries) to test the efficacy, tolerability and safety of repurposed and novel drug candidates for the treatment of LF. To address this objective, we focus our activities on 3 specific objectives:
- to develop and implement an adaptive randomised controlled phase II-III clinical platform trial evaluating drugs with proven preclinical activity against LF.
- to build capacity for sustainable and independently conducted clinical research in West Africa by developing site, laboratory and medical care capacity through North-South and South-South technology transfer and training. This activity encompasses capacity building of the lead Nigerian institution in GCP compliant clinical trial sponsorship.
- to engage communities with the proposed work plan and to assess acceptability of the trial.



Net EU contribution
€ 979 015,00
33000 Bordeaux

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Nouvelle-Aquitaine Aquitaine Gironde
Activity type
Higher or Secondary Education Establishments
Total cost
€ 979 015,00

Participants (8)

Partners (6)