Conference Abstract | Volume 8, Abstract ELIC2025183 (Oral 023) | Published: 14 Aug 2025
Marie Jaspard1,2, Camille Fritzell1, Sylvain Juchet1, Michael Ramharter3,4,5, Sylvanus Okogbenin6, INTEGRATE Study Group7
1The Alliance for International Medical Action, Dakar, Senegal, 2Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, APHP, Hôpital Saint Antoine, Service des Maladies Infectieuses et Tropicales, Paris, France, 3Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany, 4Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, 5German Center for Infection Research (DZIF), Partner Site Hamburg–Lübeck–Borstel–Riem, Hamburg, Germany, 6Irrua Specialist Teaching Hospital, Irrua, Edo State, Nigeria,
&Corresponding author: Marie Jaspard, The Alliance for International Medical Action, Dakar, Senegal, Email: marie.jaspard@coral.alima.ngo
Received: 24 Mar 2025, Accepted: 09 Jul 2025, Published: 14 Aug 2025
Domain: Infectious Disease Epidemiology
Keywords: Lassa Virus, Clinical Research, Therapeutics, West Africa
©Marie Jaspard et al. Journal of Interventional Epidemiology and Public Health (ISSN: 2664-2824). This is an Open Access article distributed under the terms of the Creative Commons Attribution International 4.0 License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Cite this article: Marie Jaspard et al., The INTEGRATE study: An adaptive platform trial for the development of new interventions to combat Lassa fever in West Africa. Journal of Interventional Epidemiology and Public Health. 2025;8(Conf Proc 5):00023. https://doi.org/10.37432/JIEPH-CONFPRO5-00023
Lassa fever (LF) is a viral haemorrhagic fever responsible for thousands of deaths per year in West Africa, with in-hospital mortality at 12%. Ribavirin is the recommended treatment of LF. However, the absence of state-of-the-art intensive care, the questionable effectiveness and the important toxicity of Ribavirin, and the high burden of LF in West Africa call for novel drug therapies.
The INTEGRATE trial is a multinational, multicentre, controlled, randomized, adaptive phase II-III platform superiority trial with open-label parallel arms. The primary objective is to compare the efficacy of Investigational Medicinal Products (IMPs) regimen to Ribavirin on prevention of death or organ failure in hospitalized adult participants. Participants are hospitalized for at least 10 days, and followed for 28 days. The platform trial evaluates IMP regimen against Ribavirin in phase II and phase III, with adaptative design in phase II depending on the IMP type. The trial is sponsored by the Irrua Specialist Teaching Hospital (ISTH) in Nigeria, with INSERM ANRS MIE, France, as a co-sponsor.
Enrollment has started in May 2025 at the Federal Medical Centre Owo, one of the largest LF treatment center in Nigeria. Next site opening to come will be at ISTH. Currently, the first IMP to be evaluated is the association of Dexamethasone and ribavirin for severe patients. Further recruiting sites across West-Africa (e.g., Liberia, Benin, Guinea, Nigeria) and further IMPs (e.g. favipiravir, ARN 75039) are planned to be added to the platform over the course of the trial. More than 500 participants are expected to join the trial over the coming years.
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