Preliminary findings from the SHINE trial for children with non-severe TB have been released. What do the results mean for young patients? Watch the researchers explain.
Publication title: Shorter treatment for minimal tuberculosis (TB) in children (SHINE)
What the trial is about:
The SHINE trial is the first randomised-controlled clinical trial designed specifically to test the efficacy of shortened treatments for children diagnosed with tuberculosis (TB). The trial’s primary concern was drug-susceptible TB that is considered minimal. This type of TB is responsive to treatment through medication, unlike drug-resistant TB, and is thought to be less severe.
The trial was funded by the UK’s department of health and social care, and the country’s department for international development’s Joint Global Health Trials Scheme, the Wellcome Trust, and the Medical Research Council (UK). University College London sponsored and coordinated the trial. The TB Alliance provided additional support.
Final data from the trial along with a summary report of the trial’s results are yet to be published.
Key take-aways from the trial:
Who took part in the trial:
- 1 204 children took part in the trial.
- SHINE participants had to be younger than 16 and weigh more than three kilograms.
- Children who were previously diagnosed with TB and received successful treatment for it could join the trial.
- Children with pre-existing conditions like liver or kidney disease were excluded from taking part in the trial.
- The young participants were selected from across four countries (Uganda, Zambia, India and South Africa. 315 of the young participants were from Cape Town) and five cities (Kampala, Lusaka, Pune, Chennai and Cape Town).
- Of the 1 204 children in the SHINE trial 127 were reported to be living with HIV.
How the trial was carried out:
- Children were randomly chosen to either get the standard six-month long course of treatment or the shorter four-month course of the same medication.
- Both groups received an initial intensive eight-week course of medications (rifampicin, isoniazid, pyrazinamide and ethambutol). The group of children on the shortened treatment plan were then given an additional eight-week course of drugs (rifampicin and isoniazid). Children receiving the standard six-month treatment plan were offered the same combination of additional medicines (rifampicin and isoniazid) but for a period of 16 weeks instead.
- The young participants were then followed for 18 months to see how they responded to the treatment.
- Researchers were looking to see if participants would be TB-free 18 months after receiving treatment.
Results from the trial:
- SHINE researchers have reported successful trial results.
- No statistically significant differences were found between children who received the shortened four-month long treatment compared to those who received the standard six-month treatment plan.
- Note: a detailed summary of the study’s results are yet to be published.