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dc.rights.licenseopenen_US
dc.contributor.authorROJO, Pablo
dc.contributor.authorMORALEDA, Cinta
dc.contributor.authorTAGARRO, Alfredo
dc.contributor.authorDOMINGUEZ-RODRIGUEZ, Sara
dc.contributor.authorCASTILLO, Lola Madrid
dc.contributor.authorTATO, Luis Manuel Prieto
dc.contributor.authorLOPEZ, Aranzazu Sancho
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.authorIROH TAM, Pui-Ying
dc.contributor.authorMVALO, Tisungane
dc.contributor.authorMAGALLHAES, Justina
dc.contributor.authorBUCK, W. Chris
dc.contributor.authorSACARLAL, Jahit
dc.contributor.authorMUSIIME, Victor
dc.contributor.authorCHABALA, Chishala
dc.contributor.authorMUJURU, Hilda Angela
dc.date.accessioned2022-07-13T11:19:11Z
dc.date.available2022-07-13T11:19:11Z
dc.date.issued2022-06-27
dc.identifier.issn1745-6215en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/140470
dc.description.abstractEnBACKGROUND: Pneumonia is the primary cause of death among HIV-infected children in Africa, with mortality rates as high as 35-40% in infants hospitalized with severe pneumonia. Bacterial pathogens and Pneumocystis jirovecii are well known causes of pneumonia-related death, but other important causes such as cytomegalovirus (CMV) and tuberculosis (TB) remain under-recognized and undertreated. The immune response elicited by CMV may be associated with the risk of developing TB and TB disease progression, and CMV may accelerate disease caused both by HIV and TB. Minimally invasive autopsies confirm that CMV and TB are unrecognized causes of death in children with HIV. CMV and TB may also co-infect the same child. The aim of this study is to compare the impact on 15-day and 1-year mortality of empirical treatment against TB and CMV plus standard of care (SoC) versus SoC in HIV-infected infants with severe pneumonia. METHODS: This is a Phase II-III, open-label randomized factorial (2 × 2) clinical trial, conducted in six African countries. The trial has four arms. Infants from 28 to 365 days of age HIV-infected and hospitalized with severe pneumonia will be randomized (1:1:1:1) to (i) SoC, (ii) valganciclovir, (iii) TB-T, and (iv) TB-T plus valganciclovir. The primary endpoint of the study is all-cause mortality, focusing on the short-term (up to 15 days) and long-term (up to 1 year) mortality. Secondary endpoints include repeat hospitalization, duration of oxygen therapy during initial admission, severe and notable adverse events, adverse reactions, CMV and TB prevalence at enrolment, TB incidence, CMV viral load reduction, and evaluation of diagnostic tests such as GeneXpert Ultra on fecal and nasopharyngeal aspirate samples and urine TB-LAM. DISCUSSION: Given the challenges in diagnosing CMV and TB in children and results from previous autopsy studies that show high rates of poly-infection in HIV-infected infants with respiratory disease, this study aims to evaluate a new approach including empirical treatment of CMV and TB for this patient population. The potential downsides of empirical treatment of these conditions include toxicity and medication interactions, which will be evaluated with pharmacokinetics sub-studies. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03915366, Universal Trial Number U111-1231-4736, Pan African Clinical Trial Registry PACTR201994797961340.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enCytomegalovirus
dc.subject.enTuberculosis
dc.subject.enValganciclovir
dc.subject.enFactorial
dc.subject.enEmpirical
dc.subject.enPneumonia
dc.subject.enHIV
dc.subject.enInfants
dc.subject.enChild mortality
dc.subject.enFactorial randomized clinical trial
dc.title.enEmpirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s13063-022-06203-1en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed35761406en_US
bordeaux.journalTrialsen_US
bordeaux.volume23en_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
hal.identifierhal-03722375
hal.version1
hal.date.transferred2022-07-13T11:19:16Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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