Show simple item record

dc.contributor.authorVessiere, A
dc.contributor.authorFont, H
dc.contributor.authorGabillard, D
dc.contributor.authorAdonis-Koffi, L
dc.contributor.authorBorand, L
dc.contributor.authorChabala, C
dc.contributor.authorKhosa, C
dc.contributor.authorMavale, S
dc.contributor.authorMoh, R
dc.contributor.authorMulenga, V
dc.contributor.authorMwanga-Amumpaire, J
dc.contributor.authorTaguebue, JV
dc.contributor.authorEang, MT
dc.contributor.authorDelacourt, C
dc.contributor.authorSeddon, JA
dc.contributor.authorLounnas, M
dc.contributor.authorGodreuil, S
dc.contributor.authorWobudeya, E
dc.contributor.authorBonnet, M
dc.contributor.authorMarcy, O
dc.date.accessioned2021-04-22T17:59:56Z
dc.date.available2021-04-22T17:59:56Z
dc.date.issued2021-03-20
dc.date.submitted2021-04-09
dc.identifier.pmid33743621
dc.identifier.doi10.1186/s12887-021-02576-5
dc.identifier.urihttp://hdl.handle.net/10144/619936
dc.description.abstractBackground: 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.en_US
dc.language.isoenen_US
dc.publisherBMCen_US
dc.rightsWith thanks to BMC.en_US
dc.subjectChildren
dc.subjectNasopharyngeal aspirate
dc.subjectPneumonia
dc.subjectStool
dc.subjectTuberculosis
dc.subjectXpert MTB/RIF ultra
dc.titleImpact 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.en_US
dc.typeArticle
dc.identifier.eissn1471-2431
dc.identifier.journalBMC Pediatricsen_US
dc.source.journaltitleBMC pediatrics
dc.source.volume21
dc.source.issue1
dc.source.beginpage136
dc.source.endpage
refterms.dateFOA2021-04-22T17:59:58Z
dc.source.countryEngland


Files in this item

Thumbnail
Name:
Vessiere et al 2021 Impact of ...
Size:
557.4Kb
Format:
PDF

This item appears in the following Collection(s)

Show simple item record