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Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics

dc.rights.licenseopenen_US
dc.contributor.authorBOURNER, Josephine
dc.contributor.authorVAILLANT, Michel
dc.contributor.authorABDEL SALAM, Alex Paddy
dc.contributor.authorJASPARD, Marie
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorFRITZELL, Camille
dc.contributor.authorJACOB, Shevin T
dc.contributor.authorFLETCHER, Tom E
dc.contributor.authorRAMHARTER, Michael
dc.contributor.authorAJAYI, Nnennaya
dc.contributor.authorOKOGBENIN, Sylvanus
dc.contributor.authorERAMEH, Cyril
dc.contributor.authorGRANT, Donald
dc.contributor.authorSAMUELS, Robert
dc.contributor.authorAYODEJI, Oladele Oluwafemi
dc.contributor.authorSPRECHER, Armand
dc.contributor.authorGONCALVES, Bronner P
dc.contributor.authorEDWARDS, Tansy
dc.contributor.authorOLLIARO, Piero
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorDUVIGNAUD, Alexandre
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorFRITZELL, Camille
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorMALVY, Denis
dc.date.accessioned2025-07-09T09:24:32Z
dc.date.available2025-07-09T09:24:32Z
dc.date.issued2025-02-01
dc.identifier.issn1080-6059en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/207278
dc.description.abstractEnThe current recommendation for treating Lassa fever with ribavirin is supported only by weak evidence. Given the persistent effects in areas with endemic transmission and epidemic potential, there is an urgent need to reassess ribavirin and investigate other potential therapeutic candidates; however, a robust clinical trial method adapted to Lassa fever epidemiology has not yet been established. We propose an adaptive phase II/III multicenter randomized controlled platform trial that uses a superiority framework with an equal allocation ratio and accounts for challenges selecting the primary end point and estimating the target sample size by using an interim analysis.
dc.language.isoENen_US
dc.subject.enLassa Fever
dc.subject.enClinical Trials
dc.subject.enPhase II/III Multicenter Randomized Controlled Platform Trial
dc.subject.enViruses
dc.title.enAdaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics
dc.title.alternativeEmerg Infect Disen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.3201/eid3102.240251en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed39983682en_US
bordeaux.journalEmerging Infectious Diseasesen_US
bordeaux.page9-16en_US
bordeaux.volume31en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue2en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDInstitut de Recherche pour le Développementen_US
hal.identifierhal-05153681
hal.version1
hal.date.transferred2025-07-09T09:24:36Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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