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
Who is funding the study?
DFID, NIHR, MRC, and Wellcome Trust Joint Global Health Trials
When is it taking place?
1st October 2018 – 30th September 2022
Where is it taking place?
Uganda, Zimbabwe, Zambia, Vietnam and India
Who is included?
Children under 15 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