• Login
    View Item 
    •   NRU
    • Journal Publications
    • Medical and Health Sciences
    • Medical and Health Sciences
    • View Item
    •   NRU
    • Journal Publications
    • Medical and Health Sciences
    • Medical and Health Sciences
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Shorter Treatment For Minimal Tuberculosis (TB) In Children (SHINE): A Study Protocol For A Randomised Controlled Trial

    Thumbnail
    View/Open
    Shorter Treatment For Minimal Tuberculosis (TB) In Children (SHINE): A Study Protocol For A Randomised Controlled Trial (954.4Kb)
    Date
    2018
    Author
    Chabala, Chishala
    Turkova, Anna
    Thomason, Margaret J.
    Wobudeya, Eric
    Hissar, Syed
    Mave, Vidya
    Zalm, Marieke van der
    Palmer, Megan
    Kapasa, Monica
    Bhavani, Perumal K.
    Balaji, Sarath
    Raichur, Priyanka A.
    Demers, Anne-Marie
    Hoddinott, Graeme
    Powell, Ellen Owen
    Kinikar, Aarti
    Musoke, Philippa
    Mulenga, Veronica
    Aarnoutse, Rob
    McIlleron, Helen
    Hesseling, Anneke
    Crook, Angela M.
    Cotton, Mark
    Gibb, Diana M.
    on behalf of the SHINE trial team
    Metadata
    Show full item record
    Abstract
    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.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.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 smear-negative 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.
    URI
    https://nru.uncst.go.ug/xmlui/handle/123456789/1703
    Collections
    • Medical and Health Sciences [3718]

    Research Dissemination Platform copyright © since 2021  UNCST
    Contact Us | Send Feedback
    Partners
     

     

    Browse

    All of NRU
    Communities & CollectionsBy Issue DateAuthorsTitlesSubjects
    This Collection
    By Issue DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    View Usage Statistics

    Research Dissemination Platform copyright © since 2021  UNCST
    Contact Us | Send Feedback
    Partners