ICTM logo
SHINE trial launches the largest ever study examining the effectiveness of treatments for children with tuberculosis

13 July 2016

This month sees the launch of the new SHINE study,  a randomised trial of shortening treatment for minimal (non-severe) tuberculosis (TB) in African and Indian children.

In 2014, an estimated 1 million children became ill with TB and 140,000 children died of TB. The disease is caused by bacteria (Mycobacterium tuberculosis) that most often affect the lungs. Treatment options are limited and expensive; recommended medicines are not always available.

Tuberculosis is preventable and curable so studies such as the SHINE trial could make treatment more affordable and manageable for patients.

The study is examining whether a shorter 4 month treatment course will be just as effective as the standard 6 month course in terms of its effectiveness and patient improvement at 72 weeks.

This is the first large-scale randomised paediatric TB treatment trial and uses a fixed-dose combination dispersible tablet, specifically formulated for children. The trial looks to enrol around 1200 participants: children under 16 years old with suspected minimal TB disease, with or without HIV infection.  The first child was enrolled on 1 July 2016 and the study is due to run for 4 years.  Children will be enrolled from clinical sites across South Africa, Zambia, Uganda and India.

The SHINE trial is being run by researchers based at the MRC Clinical Trials Unit at UCL, with funding from the Joint Global Health Trials Scheme of the Department for International Development UK (DFID), the Wellcome Trust, the Medical Research Council (MRC UK) and TB Alliance.