The SHINE trial exploring the effectiveness of tuberculosis (TB) treatment in children has led to a change in the World Health Organisation’s global guidelines for managing the disease. The research found that the treatment duration for the majority of children with drug-sensitive tuberculosis can be shortened from six to four months, thereby reducing the burden on families and healthcare systems around the world.
Lead Investigator at the Ugandan site, Dr. Eric Wobudeya will be meeting with the scientific community in Uganda to share the details of the study and discuss the implications [date and time of meeting to be announced] .
Researchers from the MRC Clinical Trials Unit at UCL worked with partners in Uganda, South Africa, Zambia and India on the SHINE study, the first randomised control trial to assess whether children with ‘minimal’ TB could be effectively treated with a shorter course of treatment.
The trial involved 1,204 children aged from two months up to 16 years with non-severe TB, who were divided randomly into two groups to take either four or six months of treatment with anti-TB medicines. Of the enrolled children, 11% were living with HIV. All children were followed for 18 months after enrolment to see whether their treatment had been successful.
The results clearly showed that children who received the shorter course did as well as those on the standard six-month treatment, regardless of the age group, country or HIV status, with few and similar side effects in both groups.
The World Health Organisation Guidelines Development Group reviewed the evidence from SHINE and recommended in August 2021 that presumed drug susceptible TB, a four-month regimen should be used rather than the standard six-month regimen in children and adolescents with non-severe.
Important considerations about how to determine eligibility for the shorter treatment regimen will be described in WHO’s full consolidated guidelines coming out in 2022 and in the operational handbook.
The SHINE trial was funded by the Joint Global Health Trials scheme, including the Department for Health and Social Care, the Foreign, Commonwealth and Development Office, the Medical Research Council and the Wellcome Trust. This UK-funded award is part of the EDCTP2 Programme supported by the European Union.
Additional partners included Stellenbosch University, South Africa; University of Cape Town, South Africa; National Institute for Research in Tuberculosis, India; Radboud University Medical Center, the Netherlands; International Union Against Tuberculosis and Lung Disease, France; University of Melbourne, Australia; University of York; Imperial College London and University Hospitals Birmingham.
MU-JHU Care LTD is an HIV research, care prevention and training facility located on Upper Mulago Hill in the city of Kampala. In 1988, we started as a collaboration between researchers from Makerere University and Johns Hopkins University in Baltimore, USA ( US-based researchers were originally based at Case Western Reserve University). Our initial mission was to improve the lives of families infected and affected by HIV through Research, Care and Training. Up until 2006, we operated under the name MU-JHU Research Collaboration. In the same year, we registered as a not-for-profit, entity in Uganda entitled ‘MU-JHU Care Limited’ with a continuation of the Collaboration’s vision and mission.
MU-JHU has conducted several landmark research studies, which have informed global and national policy. These studies paved the way to eliminate mother-to-child HIV transmission and improve maternal and paediatric HIV care. Over the last decade, MU-JHU has progressively expanded its clinical and implementation science-research portfolio to include:
MU-JHU partners with many local and international academic and clinical partners to achieve its mission building on its longstanding Clinical Research Site affiliated with Johns Hopkins University.
Notes to Editors
For more information or to speak to the researchers involved, please contact
Romana Brenda Nabbosa, T: +256 752 307 101, E: rnabbosa@mujhu.org