Stellenbosch TB trial proves children can be cured much sooner
Young children with less severe TB can be cured in four months instead of the usual six months prescribed by the law, a new treatment study has found.
This was discovered after a trial involving more than 1,200 children from India, SA, Uganda and Zambia was conducted at the Desmond Tutu TB Centre (DTTC) at Stellenbosch University recently.
Prof Anneke Hesseling of the faculty of medicine and health sciences at SU said this had been the first trial to confirm their suspicion.
“The SHINE trial is the first tuberculosis treatment-shortening randomised-controlled clinical trial in children. It’s a milestone. We’ve suspected for a long time that we are over-treating many children with TB, but now have clear, pragmatic evidence to inform policy and clinical practice,” said Hesseling.
Hesseling said around 1.1 million children developed TB annually, with nearly 205,000 succumbing to the virus each year. Children and adolescents accounted for around 25% of TB cases in Africa.
Hesseling, however, said treatment options for children had lagged those available to adults.
“The SHINE trial compared a shortened four-month treatment regimen with the standard six-month regimen, using the same medications, and showed that 93% of children with minimal TB were successfully treated, with no difference in outcome between the regimens,” she said.
Hesseling emphasised that this applied only to children with “minimal TB”, which is not that severe.
“It’s typically pulmonary TB with minimal changes in the lungs, no cavities, complications or dissemination of the TB bacilli. It also applies to mild TB outside the lung — typically lymph node disease. We used chest X-rays to look for standard patterns or features which we classify as not severe, and which doctors on site used to randomise children.”
She described the milestone as a victory as it meant up to 50%-60% of children had minimal TB globally and in SA could benefit from the treatment.
“It’s important to treat all forms of TB, including minimal TB, rapidly and effectively, so that it does not progress to a more severe form of the disease, especially in young, immune-compromised or malnourished children.
“If you treat minimal disease rapidly with a shorter regimen, the disease does not progress, and the regimen cures children, so it’s rewarding to have such good outcomes in this trial,” said Hesseling.
SU said the shortened treatment will have an economic and societal impact, and also make a difference to the health services.
“Children usually have lower bacterial levels, which have now been proven to respond equally well to shorter treatment. It’s an approach tailored to the child and to the disease. It’s difficult to get a child to take antibiotics daily for six months. Reducing this by two months relieves the burden on families, caregivers and health services.”
Hesseling explained that the World Health Organisation (WHO) was collecting evidence to inform their 2021 TB treatment guidelines, and it is expected that these results will inform the relevant guidelines for TB.
“We will ensure that our results are rapidly disseminated to local and global programme partners, communities and other stakeholders, to prepare for policy changes and practical implementation. I think this will be welcomed in SA,” she said.
She applauded the DTTC and the highly engaged TB programme in the country on the “high-quality” evidence that can be translated practically to treat children clinically.
“For the DTTC this has been an amazing journey. We have built capacity to do large-scale TB-treatment trials; we have made inputs into key methodological aspects; and we have strengthened relationships with health services and communities.
“Training around reading X-rays across all five sites in Africa and India has built confidence in the robustness of these processes. It’s been a rich collaboration with opportunities for knowledge exchange on which to build for future TB treatment trials in children,” added Hesseling.