SURE

A randomised trial of 6 months intensified anti-tuberculosis and 2 months anti-inflammatory treatment for HIV-infected and HIV-uninfected African and Asian children with tuberculous meningitis

Can a shorter, more intensified anti-TB regimen be as effective as the current regimen? And can aspirin given for 2 months effectively decrease the chances of developing neurological long-term problems?

What is this study about?

This trial aims to answer two questions. Firstly, for children presenting with TBM (a form of tuberculosis that affects the lining of the brain) who are given a shorter and more intensified treatment for their TBM, is this treatment as effective as the standard treatment in preventing TBM-related deaths?

Secondly, if in addition to the anti-TB treatment, the children are given aspirin for the first 2 months after diagnosis, does this prevent long-term neurological disability in these children?

To answer both questions, we will conduct a partially blinded, placebo-controlled, randomised clinical trial.

Type of study

Randomised trial

Contact details

mrcctu.sure@ucl.ac.uk

Who is funding the study?

SURE is funded by the UK Department for International DevelopmentNational Institute for Health and Care ResearchMedical Research Council, and the Wellcome Trust Joint Global Health Trials.

When is it taking place?

The trial opened to recruitment in March 2021 and closed in July 2024. Follow-up is due to end in November 2025.

Where is it taking place?

The trial takes place in Uganda, Zimbabwe, Zambia, Vietnam and India.

Who is included?

Children under 18 years and over 28 days of age with TBM disease (a form of tuberculosis that affects the lining of the brain), with or without HIV infection