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ISTH/ANRS 0409s INTEGRATE Lassa Fever Study

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Start date changed from estimate of Jul 1, 2024 to May 2, 2025
    • Study sites: 0 to 4
    • Interventions: Dexamethasone (Drug), Favipiravir (Drug), Ribavirin (Drug) to ARN-75039 high dose (Drug), ARN-75039 low dose (Drug), Dexamethasone (Drug), Favipiravir (Drug), Ribavirin (Drug)
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 24 to 27
    • Study arms: 4 to 6
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Lassa fever (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. Transmission to humans occurs mainly via direct or indirect exposure to excreta from the rodent reservoir, mainly made up of Mastomys natalensis . Less frequently, LASV may also be transmitted from human to human and cause nosocomial outbreaks. Ribavirin is the only treatment available with worrying toxicity, questionable efficacy and low access because of its high cost. Consequently, there is an urgent need for new drugs to treat LF patients. The Research and Development (R\&D) Blueprint of the World Health Organization (WHO) has included LF in the list of priority diseases for urgent research and development. The INTEGRATE consortium is an unprecedented international collaboration on Lassa fever of 15 partners from 10 countries across West Africa, Europe and North America and across several disciplines (epidemiological researchers, social scientists, medical health facility professionals, humanitarian actors, etc.).
Trial Details
NCT Number NCT06212336
Lead Sponsor Irrua Specialist Teaching Hospital
Collaborators: Alliance for International Medical Action, University of Bordeaux, Bernhard Nocht Institute for Tropical Medicine, Federal Medical Centre, Owo, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Fondation pour la Recherche Scientifique, Benin, Médecins Sans Frontières, Belgium, Alex Ekwueme Federal University Teaching Hospital, Donka Hospital, Conakry, Centre de Recherche Médicale de Lambaréné, University of Hamburg-Eppendorf, Phebe Hospital, Liberia, University of North Carolina, ANRS, Emerging Infectious Diseases
Conditions
(from sponsor)		 Lassa Fever
Related terms Communicable Diseases, Emerging, Hemorrhagic Fevers, Viral, Lassa Fever
Enrollment 1,755 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov