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Shorter, more intensive treatment for TB meningitis in children is not as effective as the standard treatment

19 Nov 2025

Results from the SURE trial showed that, for children with tuberculosis (TB) meningitis, a shorter, more intensive treatment is not as good as the current standard treatment. Adding high-dose aspirin during the first two months of treatment also did not show any benefit. These results were presented today at The Union World Conference on Lung Health in Copenhagen, Denmark.

TB meningitis is a rare but serious form of TB in children which affects the brain and the spinal cord. It is a devastating disease in children. Even with treatment, more than one in five children with TB meningitis die from the disease. Among those who survive, up to half may experience long-term neurological disabilities such as difficulty in mobilising independently, language delay and behavioural and cognitive problems. These disabilities can affect their quality of life and place a heavy burden on families and health systems.

The standard treatment used for decades to treat TB meningitis and recommended by the World Health Organization (WHO) lasts 12 months and is based on drugs designed for lung TB, which may not work as well for TB meningitis. In 2022 the WHO published new guidance advising that a shorter, six-month, more intensive treatment regimen (the “Cape Town” regimen) could be used as an alternative treatment option for children and adolescents with drug-susceptible TB meningitis. However, the efficacy of this six month, more intensive treatment versus 12 months standard treatment has never been tested in a randomised clinical trial. If it works well, a shorter treatment could be easier for children to complete and have lower costs for families and health services.

The SURE trial had two aims. The first was to find out whether a shorter, more intensive treatment could be as good as the standard 12-month treatment in preventing deaths from TB meningitis. SURE compared these two treatments:

  • Shorter, intensive treatment: four drugs with higher doses of rifampicin (R) (30 mg/ kg),isoniazid (H) (20 mg/kg), pyrazinamide (Z) (40 mg/kg) and levofloxacin (L) (20 mg/kg), given for six months. This regimen was similar but not identical to the alternative “Cape Town” regimen recommended by WHO; the difference being that the SURE shorter, intensive treatment used levofloxacin instead of ethionamide (Eto). Both drugs enter the brain well and levofloxacin has the added advantage of being active against some strains that are resistant to isoniazid.
  • Standard treatment: WHO’s standard 12-month treatment regimen, consisting of 2-months of four drugs (isoniazid (H), rifampicin (R),), pyrazinamide (Z) and ethambutol (E), HRZE) followed by 10-months of two drugs (HR). In India, the standard treatment was 10 months of three drugs (HRE). The doses of HR were lower than in the intensive 6-month group.

The second aim was to test whether giving aspirin at high doses for the first two months of treatment could reduce death and neurological disability in children with TB meningitis.

A total of 369 children aged between 29 days and less than18 years with clinically diagnosed, drug-susceptible TB meningitis took part. They were randomly allocated to receive either the shorter, intensive treatment or the standard treatment; and to take either high-dose aspirin or placebo.

SURE is the largest clinical trial to-date in children with TB meningitis. It was carried out in India, Uganda, Vietnam, Zambia and Zimbabwe.

The SURE trial showed that both anti-TB treatments work. Overall, children in the SURE trial did better than expected based on previous research. More children survived (86%), and more children were free from disability (80%).

However, results from the SURE trial did not show that the shorter, more intensive treatment is as good as the standard 12-month treatment in preventing deaths. By 48 weeks of follow-up, 16% of children had died receiving the shorter, intensive treatment, compared to 12% receiving the standard treatment.

SURE also showed no evidence that adding high-dose aspirin for the first two months of treatment had any benefit in children with TB meningitis. By 48 weeks of follow-up, SURE found that the proportion of children with severe disability or that had died was 22% in the aspirin group vs 15% in the placebo group, showing a non-significant trend towards harm.  

In terms of safety, more children in the shorter, intensive treatment group had side-effects. These were mainly liver problems from the anti-TB drugs. As a result, more children in the shorter, intensive treatment had to move to liver-friendly treatment regimens, which may be less effective. However, most children did eventually go back on their shorter, intensive treatment without further problems.

Based on these findings at 48-weeks, we cannot recommend the shorter, more intensive treatment used in SURE, nor adding aspirin, for children with TB meningitis.

To better understand these results and learn more about TB meningitis in children, the SURE team is also carrying out sub-studies linked to the trial. They include studies looking at:

  • How TB meningitis damages the brain, and how this results in disability
  • The spectrum and severity of disability in children who survive TB meningitis
  • How the TB drug levels in blood and cerebral spinal fluid change and vary between different populations and influence side-effects
  • The social and economic impact of TB meningitis
  • How to improve diagnosis of TB meningitis

The SURE trial is continuing to follow-up participants up to 72 weeks, and further results will be available next year.

The SURE trial is funded by the National Institute for Health Research (NIHR), the Foreign, Commonwealth & Development Office (FCDO), the Medical Research Council (MRC) and the Wellcome Trust. Grant reference number: MR/R006113/1. This UK-funded award is part of the EDCTP2 programme supported by the European Union. This work was supported by core funding from the UK Medical Research Council (MC_UU_00004/04).

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