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Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial

dc.rights.licenseopenen_US
dc.contributor.authorDOMINGUEZ-RODRIGUEZ, Sara
dc.contributor.authorLORA, David
dc.contributor.authorTAGARRO, Alfredo
dc.contributor.authorMORALEDA, Cinta
dc.contributor.authorBALLESTEROS, Alvaro
dc.contributor.authorMADRID, Lola
dc.contributor.authorMANUKYAN, Lilit
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorMARCY, Olivier
dc.contributor.authorLEROY, Valeriane
dc.contributor.authorNARDONE, Alessandra
dc.contributor.authorBURGER, David
dc.contributor.authorBASSAT, Quique
dc.contributor.authorBATES, Matthew
dc.contributor.authorMOH, Raoul
dc.contributor.authorTAM, Pui-Ying Iroh
dc.contributor.authorMVALO, Tisungane
dc.contributor.authorMAGALLHAES, Justina
dc.contributor.authorBUCK, W Chris
dc.contributor.authorSACARLAL, Jahit
dc.contributor.authorMUSSIME, Victor
dc.contributor.authorCHABALA, Chishala
dc.contributor.authorMUJURU, Hilda Angela
dc.contributor.authorROJO, Pablo
dc.contributor.authorGROUP, Empirical
dc.date.accessioned2025-05-28T12:45:04Z
dc.date.available2025-05-28T12:45:04Z
dc.date.issued2025-04-30
dc.identifier.issn1745-6215en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/206772
dc.description.abstractEnBACKGROUND: The EMPIRICAL trial aims to assess safety and efficacy of an empirical treatment against cytomegalovirus (CMV) and tuberculosis (TB) compared to standard of care (SoC), on adverse events and 15-day and 1-year mortality among infants living with HIV hospitalized with severe pneumonia in Africa. METHODS AND DESIGN: The EMPIRICAL trial (NCT03915366) is an international multicenter phase II-III, open-label randomized factorial clinical trial conducted in six African countries. The trial has four randomization arms in a 1:1:1:1 fashion with patients allocated to (i) TB-Treatment plus SoC, (ii) valganciclovir plus SoC, (iii) both TB-Treatment and valganciclovir plus SoC, and (iv) SoC only. DISCUSSION: This paper describes the statistical analysis plan (SAP) for the trial which, per the study publication plan, needs to be published prior to the database lock and final analysis results. The SAP includes details of the analyses to be undertaken and unpopulated tables that will be reported to address primary and secondary endpoints. The database will be locked on 31st January 2025. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03915366 (registered on April 16, 2019), Universal Trial Number: U111-1231-4736, Pan African Clinical Trial Registry: PACTR201994797961340.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enChild mortality
dc.subject.enCytomegalovirus
dc.subject.enEmpirical
dc.subject.enFactorial
dc.subject.enFactorial randomized clinical trial
dc.subject.enHIV
dc.subject.enInfants
dc.subject.enPneumonia
dc.subject.enStatistical analysis plan
dc.subject.enTuberculosis
dc.subject.enValganciclovir
dc.title.enStatistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial
dc.title.alternativeTrialsen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s13063-025-08841-7en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed40307889en_US
bordeaux.journalTrialsen_US
bordeaux.page144en_US
bordeaux.volume26en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_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-05088672
hal.version1
hal.date.transferred2025-05-28T12:45:09Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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