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

Simple item page
dc.contributor.authorVessiere, Aureliaen_ZA
dc.contributor.authorFont, Heleneen_ZA
dc.contributor.authorGabillard, Delphineen_ZA
dc.contributor.authorAdonis-Koffi, Laurenceen_ZA
dc.contributor.authorBorand, Laurenceen_ZA
dc.contributor.authorChabala, Chishalaen_ZA
dc.contributor.authorKhosa, Celsoen_ZA
dc.contributor.authorMavale, Sandraen_ZA
dc.contributor.authorMoh, Raoulen_ZA
dc.contributor.authorMulenga, Veronicaen_ZA
dc.contributor.authorMwanga-Amumpere, Julieten_ZA
dc.contributor.authorTaguebue, Jean-Voisinen_ZA
dc.contributor.authorEang, Mao T.en_ZA
dc.contributor.authorDelacourt, Christopheen_ZA
dc.contributor.authorSeddon, James A.en_ZA
dc.contributor.authorLounnas, Manonen_ZA
dc.contributor.authorGodreuil, Sylvainen_ZA
dc.contributor.authorWobudeya, Ericen_ZA
dc.contributor.authorBonnet, Marylineen_ZA
dc.contributor.authorMarcy, Olivieren_ZA
dc.date.accessioned2021-04-29T10:32:40Z
dc.date.available2021-04-29T10:32:40Z
dc.date.issued2021-03-20
dc.date.updated2021-03-21T04:28:28Z
dc.descriptionCITATION: Vessiere, A., et al. 2021. 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. BMC Pediatrics, 21:136, doi:10.1186/s12887-021-02576-5.
dc.descriptionThe original publication is available at https://bmcpediatr.biomedcentral.com
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 postdischarge, 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.description.urihttps://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-021-02576-5
dc.description.versionPublisher's version
dc.format.extent12 pagesen_ZA
dc.identifier.citationVessiere, A., et al. 2021. 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. BMC Pediatrics, 21:136, doi:10.1186/s12887-021-02576-5
dc.identifier.issn1471-2431 (online)
dc.identifier.otherdoi:10.1186/s12887-021-02576-5
dc.identifier.urihttp://hdl.handle.net/10019.1/110408
dc.language.isoen_ZAen_ZA
dc.publisherBMC (part of Springer Nature)en_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectPneumonia in childrenen_ZA
dc.subjectNasopharyngitisen_ZA
dc.subjectTuberculosisen_ZA
dc.subjectMolecular diagnosisen_ZA
dc.subjectTuberculosis -- Early detectionen_ZA
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 trialen_ZA
dc.typeArticleen_ZA
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
vessiere_impact_2021.pdf
Size:
557.47 KB
Format:
Adobe Portable Document Format
Description:
Download article
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
0 B
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Research Articles (Desmond Tutu TB Centre)