Groundbreaking SA study shapes global TB treatment guidelines

The results of a groundbreaking local clinical study have become the world’s first initiative in the fight against drug-resistant tuberculosis for all population groups, influencing World Health Organisation (WHO) policy.

BEAT Tuberculosis is a clinical study conducted at the Clinical HIV Research Unit (CHRU) Isango Lethemba TB Research Unit in the Eastern Cape and KwaZulu-Natal (KZN) over the past six years.

The study was born out of the need to find better treatment options for drug-resistant TB, and the main intention was to inform local guidelines.

Study influence WHO TB treatment policy

The study was in collaboration with the South African Department of Health, funded by the US Agency for International Development (USAID) and executed by Wits University.

The results from the study have influenced the WHO policy on the treatment of TB and put the Global South centre stage for driving improved treatment for all.

This was announced in a joint statement by the department, CHRU, the Wits Health Consortium, and USAID on Wednesday.

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Pregnant women and children included

The principal investigator who led the study, Dr Francesca Conradie said the study represents a “groundbreaking approach” in the fight against TB, particularly with its inclusive research methodology.

“By incorporating pregnant women and children into the clinical trials, the study has expanded the understanding of TB treatment’s efficacy and safety across broader demographics,” said Conradie.

“The study’s success in demonstrating safety and effectiveness of the new short oral regimen in these key populations marks a pivotal step towards a more comprehensive and equitable healthcare strategy for tuberculosis management.”

According to the organisations, the main objective was to compare a novel, shorter treatment regimen for drug-resistant TB with the accepted standard of care in order to assess its efficacy and safety.

Over 400 participants from EC and KZN

The second objective was to enhance research capacity for drug-resistant TB within the Eastern Cape and KwaZulu-Natal by fostering community engagement and providing training to healthcare personnel in clinical research methodologies for TB treatment.

The study began in 2019, and despite challenges posed by Covid-19, over 400 participants were enrolled across study sites.

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The department’s chief director, TB Control and Management Professor Norbert Ndjeka said in 2022, an estimated 280 000 people developed TB and 54 000 died from the disease in South Africa.

“With this concerning observation in mind, we acknowledge the BEAT Tuberculosis project as an exemplary and concerted effort to advance TB treatment and research capabilities, poised to bring about transformative changes in Rifampicin-resistant TB (RR-TB) management worldwide,” Ndjeka said.

“While the study was originally intended to inform local treatment guidelines, the results are now set to benefit patients everywhere.”

Improved TB patient care

USAID Southern Africa mission director, Leslie Marbury, said USAID has improved TB patient care worldwide in partnership with the department.

“We celebrate the 400 participants who made this trial possible and brought the world closer to ending Tuberculosis,” Marbury said.

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