A randomised trial of therapy shortening for minimal tuberculosis with new WHO-recommended doses/fixed-dose-combination drugs in African and Indian HIV+ and HIV- children
Shorter treatment for minimal TB in children
What is this study about?
Tuberculosis (TB) continues to be a major health problem in many countries. Of the estimated 9 million new TB cases every year across the world, about one million (11%) are in children with the majority in Africa and South East Asia. Children often have mild forms of TB and it is likely that they could be successfully treated for less than the standard 6 months. This would have major advantages for the child, their family and carers, and for overburdened health systems, by reducing the number of clinic visits children need to make to take their drugs.
This study is examining whether a shorter 4-month regimen will be non-inferior to the standard 6-month regimen in terms of unfavourable outcomes at 72 weeks.
Type of study
Who is funding the study?
Joint Global Health Trials Scheme of the Department for International Development, UK (DFID), the Wellcome Trust and the UK Medical Research Council (MRC UK).
When is it taking place?
The trial started in July 2016. Recruitment and follow up are expected to be completed by the end of 2018, with results available end of 2020.
Where is it taking place?
South Africa (Stellenbosch), Zambia (Lusaka), Uganda (Kampala) and India (Chennai and Pune).
Who is included?
Children < 16 years with suspected non-severe (limited) TB disease, with or without HIV infection.