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Impact of systematic early tuberculosis detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries (TB-Speed pneumonia): a stepped wedge cluster randomized trial

dc.rights.licenseopenen_US
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorVESSIERE, Aurelia
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorFONT, Helene
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorGABILLARD, Delphine
dc.contributor.authorADONIS-KOFFI, Laurence
dc.contributor.authorBORAND, Laurence
dc.contributor.authorCHABALA, Chishala
dc.contributor.authorKHOSA, Celso
dc.contributor.authorMAVALE, Sandra
dc.contributor.authorMOH, Desmorys Raoul
dc.contributor.authorMULENGA, Veronica
dc.contributor.authorMWANGA-AMUMPERE, Juliet
dc.contributor.authorTAGUEBUE, Jean-Voisin
dc.contributor.authorEANG, Mao Tan
dc.contributor.authorDELACOURT, Christophe
dc.contributor.authorSEDDON, James A.
dc.contributor.authorLOUNNAS, Manon
dc.contributor.authorGODREUIL, Sylvain
dc.contributor.authorWOBUDEYA, Eric
dc.contributor.authorBONNET, Maryline
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMARCY, Olivier
dc.date.accessioned2021-05-12T13:45:20Z
dc.date.available2021-05-12T13:45:20Z
dc.date.issued2021-03-20
dc.identifier.issn1471-2431 (Electronic) 1471-2431 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/74546
dc.description.abstractEnBackground: In high tuberculosis (TB) burden settings, there is growing evidence that TB is common in children with pneumonia, the leading cause of death in children under 5 years worldwide. The current WHO standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. As a result, many children with TB-associated severe pneumonia are currently missed or diagnosed too late. We therefore propose a diagnostic trial to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra (Ultra) performed on nasopharyngeal aspirates (NPA) and stool samples to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples. Methods: TB-Speed Pneumonia is a pragmatic stepped-wedge cluster randomized controlled trial conducted in six countries with high TB incidence rate (Côte d’Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia). We will enrol 3780 children under 5 years presenting with WHO-defined severe pneumonia across 15 hospitals over 18 months. All hospitals will start managing children using the WHO SOC for severe pneumonia; one hospital will be randomly selected to switch to the intervention every 5 weeks. The intervention consists of the WHO SOC plus rapid TB detection on the day of admission using Ultra performed on 1 nasopharyngeal aspirate and 1 stool sample. All children will be followed for 3 months, with systematic trial visits at day 3, discharge, 2 weeks post-discharge, and week 12. The primary endpoint is all-cause mortality 12 weeks after inclusion. Qualitative and health economic evaluations are embedded in the trial. Discussion: In addition to testing the main hypothesis that molecular detection and early treatment will reduce TB mortality in children, the strength of such pragmatic research is that it provides some evidence regarding the feasibility of the intervention as part of routine care. Should this intervention be successful, safe and well tolerated, it could be systematically implemented at district hospital level where children with severe pneumonia are referred.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enChildren
dc.subject.enPneumonia
dc.subject.enTuberculosis
dc.subject.enNasopharyngeal aspirate
dc.subject.enStool
dc.subject.enXpert MTB/RIF ultra
dc.title.enImpact of systematic early tuberculosis detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries (TB-Speed pneumonia): a stepped wedge cluster randomized trial
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s12887-021-02576-5en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed33743621en_US
bordeaux.journalBMC Pediatricsen_US
bordeaux.page136en_US
bordeaux.volume21en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamIDLICen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03225491
hal.version1
hal.date.transferred2021-05-12T13:45:25Z
hal.exporttrue
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