Shorter treatment for minimal tuberculosis (TB) in children (SHINE) : a study protocol for a randomised controlled trial

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dc.contributor.authorChabala, Chishalaen_ZA
dc.contributor.authorTurkova, Annaen_ZA
dc.contributor.authorThomason, Margaret J.en_ZA
dc.contributor.authorWobudeya, Ericen_ZA
dc.contributor.authorHissar, Syeden_ZA
dc.contributor.authorMave, Vidyaen_ZA
dc.contributor.authorVan Der Zalm, Mariekeen_ZA
dc.contributor.authorPalmer, Meganen_ZA
dc.contributor.authorKapasa, Monicaen_ZA
dc.contributor.authorBhavani, Perumal K.en_ZA
dc.contributor.authorBalaji, Sarathen_ZA
dc.contributor.authorRaichur, Priyanka A.en_ZA
dc.contributor.authorDemers, Anne-Marieen_ZA
dc.contributor.authorHoddinott, Graemeen_ZA
dc.contributor.authorOwen-Powell, Ellenen_ZA
dc.contributor.authorKinikar, Aartien_ZA
dc.contributor.authorMusoke, Philippaen_ZA
dc.contributor.authorMulenga, Veronicaen_ZA
dc.contributor.authorAarnoutse, Roben_ZA
dc.contributor.authorMcIlleron, Helenen_ZA
dc.contributor.authorHesseling, Annekeen_ZA
dc.contributor.authorCrook, Angela M.en_ZA
dc.contributor.authorCotton, Marken_ZA
dc.contributor.authorGibb, Diana M.en_ZA
dc.date.accessioned2018-04-23T05:40:22Z
dc.date.available2018-04-23T05:40:22Z
dc.date.issued2018-04-19
dc.date.updated2018-04-22T03:29:26Z
dc.descriptionCITATION: Chabala, C., et al. 2018. Shorter treatment for minimal tuberculosis (TB) in children (SHINE) : a study protocol for a randomised controlled trial. Trials, 19:237, doi:10.1186/s13063-018-2608-5.
dc.descriptionThe original publication is available at https://trialsjournal.biomedcentral.com
dc.description.abstractBackground: Tuberculosis (TB) in children is frequently paucibacillary and non-severe forms of pulmonary TB are common. Evidence for tuberculosis treatment in children is largely extrapolated from adult studies. Trials in adults with smear-negative tuberculosis suggest that treatment can be effectively shortened from 6 to 4 months. New paediatric, fixed-dose combination anti-tuberculosis treatments have recently been introduced in many countries, making the implementation of World Health Organisation (WHO)-revised dosing recommendations feasible. The safety and efficacy of these higher drug doses has not been systematically assessed in large studies in children, and the pharmacokinetics across children representing the range of weights and ages should be confirmed. Methods/design: SHINE is a multicentre, open-label, parallel-group, non-inferiority, randomised controlled, two-arm trial comparing a 4-month vs the standard 6-month regimen using revised WHO paediatric anti-tuberculosis drug doses. We aim to recruit 1200 African and Indian children aged below 16 years with non-severe TB, with or without HIV infection. The primary efficacy and safety endpoints are TB disease-free survival 72 weeks post randomisation and grade 3 or 4 adverse events. Nested pharmacokinetic studies will evaluate anti-tuberculosis drug concentrations, providing model-based predictions for optimal dosing, and measure antiretroviral exposures in order to describe the drug-drug interactions in a subset of HIV-infected children. Socioeconomic analyses will evaluate the cost-effectiveness of the intervention and social science studies will further explore the acceptability and palatability of these new paediatric drug formulations. Discussion: Although recent trials of TB treatment-shortening in adults with sputum-positivity have not been successful, the question has never been addressed in children, who have mainly paucibacillary, non-severe smearnegative disease. SHINE should inform whether treatment-shortening of drug-susceptible TB in children, regardless of HIV status, is efficacious and safe. The trial will also fill existing gaps in knowledge on dosing and acceptability of new anti-tuberculosis formulations and commonly used HIV drugs in settings with a high burden of TB. A positive result from this trial could simplify and shorten treatment, improve adherence and be cost-saving for many children with TB.en
dc.description.sponsorshipSHINE is funded by the Joint Global Health Trials Scheme of the Department for International Development, UK (DFID), the Wellcome Trust and the Medical Research Council (MRC UK), Grant number MR/L004445/1; and TB Alliance. This work was supported by core support to the UK Medical Research Council [MC_UU_12023/26].
dc.description.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2608-5
dc.description.versionPublisher's version
dc.format.extent12 pages ; illustrations
dc.identifier.citationChabala, C., et al. 2018. Shorter treatment for minimal tuberculosis (TB) in children (SHINE) : a study protocol for a randomised controlled trial. Trials, 19:237, doi:10.1186/s13063-018-2608-5
dc.identifier.issn1745-6215 (online)
dc.identifier.otherdoi:10.1186/s13063-018-2608-5
dc.identifier.urihttp://hdl.handle.net/10019.1/103972
dc.language.isoen_ZAen_ZA
dc.publisherBioMed Central
dc.rights.holderAuthors retain copyright
dc.subjectTuberculosis -- Childrenen_ZA
dc.subjectClinical trialsen_ZA
dc.titleShorter treatment for minimal tuberculosis (TB) in children (SHINE) : a study protocol for a randomised controlled trialen_ZA
dc.typeArticleen_ZA
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