A South African clinical study that began in a research unit in Gqeberha (PE), Eastern Cape, has transformed global treatment of drug-resistant tuberculosis. Furthermore, the study’s findings were published this week in the New England Journal of Medicine (NEJM), the highest-ranked medical journal in the world.
The publication recognises that this research study has set the global standard for TB care.
The BEAT Tuberculosis clinical study, conducted at the Clinical Health Research Unit (CHRU) Isango Lethemba TB Research Unit in the Eastern Cape and King Dinizulu Hospital Complex in KwaZulu-Natal, enrolled more than 400 participants over two years during the Covid-19 pandemic.
The study was executed by the University of the Witwatersrand in collaboration with the National Department of Health and funded by the United States Agency for International Development (USAID).
“This project has gone full circle,” says Dr Francesca Conradie, principal investigator of BEAT Tuberculosis and a researcher at the Clinical Health Research Unit (CHRU), University of the Witwatersrand. “The results from this trial have changed international guidelines. Being published in the New England Journal of Medicine is proof that South Africa produces world-class research that improves the lives of patients globally.”
Treatment for the whole family
The primary aim of BEAT Tuberculosis was to evaluate the safety and effectiveness of a novel, shortened treatment regimen for DR-TB compared with the established standard of care. The standard treatment at the time required a seven-drug regimen administered over a minimum of nine months. BEAT Tuberculosis tested a streamlined regimen of four to five medications, including the newer agents bedaquiline and delamanid, administered over six months.
The BEAT Tuberculosis trial enrolled children, pregnant women and breastfeeding mothers alongside adults. These former groups are usually excluded from clinical research. The result is a treatment regimen that can be used across the entire family.
“This is a one-size-fits-all treatment regimen,” explains Conradie. “Adherence is much easier when the three-year-old, the teenager, the mother and the father are all receiving treatment of similar duration and composition. That simplicity saves lives.”
The study enrolled 10 pregnant women. All 10 women gave birth to healthy babies, and nine of them were successfully treated. BEAT Tuberculosis has since been cited internationally as a model for inclusive clinical research methodology, and the findings have influenced World Health Organization policy on the treatment of DR-TB globally, including for pregnant women and children.
South Africa’s National Clinical Advisory Committee already reviews and approves the regimen for pregnant women presenting with Drug-Resistant TB, while other provinces are adopting the treatment, particularly when treating children.
During 2024, South Africa had 249,000 people who were infected with active tuberculosis, and 54 000 died from the disease,” says Professor Norbert Ndjeka, Chief Director: TB Control and Management, National Department of Health. “Not only did BEAT TB produce world-class research, but it is also being implemented progressively across South Africa and globally and is internationally recognised. South Africa has accomplished something exceptional.”
Source: Wits University
