Health, South Africa (Commonwealth Union) – A groundbreaking clinical trial revealed last week at the Union Conference on Lung Health in Paris has demonstrated that a six-month course of a daily oral antibiotic significantly diminishes the risk of developing drug-resistant tuberculosis (TB). Researchers from the Desmond Tutu TB Centre at Stellenbosch University’s Faculty of Medicine and Health Sciences (FMHS) shared that the antibiotic levofloxacin effectively reduced the risk of multidrug-resistant (MDR) tuberculosis in children by an impressive 56%. The trial, funded by Unitaid, also affirmed the exceptional safety of administering levofloxacin once daily to children over the span of six months.
Until now, there has been limited evidence regarding preventive treatments for MDR-TB, as no randomized controlled trials had been undertaken. The TB-CHAMP trial unfolded in South Africa across six research sites in five provinces, targeting communities burdened with high rates of TB and MDR-TB, with a primary focus on children under the age of five.
Professor Anneke Hesseling, Director of the Desmond Tutu TB Centre and the lead investigator of the TB-CHAMP trial at Stellenbosch University, emphasized the scarcity of rigorous data on preventing drug-resistant TB despite numerous advancements in preventing drug-susceptible TB. She indicated that they have now identified a safe method to shield children in households with an MDR-TB adult, underscoring the vital importance of safeguarding children from drug-resistant diseases. The potential benefits for children, their families, and communities are considerable.
“MDR-TB is one of the toughest diseases to cure, and children have always been the most neglected patients,” explained Professor James Seddon, who is co-Principal Investigator from TB-CHAMP from Stellenbosch University. “In finding a new way to keep children safe when MDR-TB afflicts a family member, we help the whole family recover that much faster from the trauma that the disease inflicts—not just from a health perspective, but from economic and mental health perspectives as well.”
“Research to prevent and treat tuberculosis in children has been treated as an afterthought for far too long,” added Dr Philippe Duneton, Executive Director of Unitaid, the largest multilateral funder of TB research and development across the world. “Unitaid is pleased to be a part of efforts to elevate children’s needs. This first of its kind evidence into the prevention of drug-resistant TB in children is a major advance that has the potential to protect millions of children from a debilitating illness.”
In the TB-CHAMP trial, 453 children who had been exposed to an adult with multidrug-resistant tuberculosis (MDR-TB) in their household were administered levofloxacin, and only 5 of them developed MDR-TB. The occurrence of side effects from the medication was minimal, with joint pain and tendonitis—common concerns—being exceptionally rare in children receiving levofloxacin.
Globally, TB remains a leading cause of death in children, particularly those under 5 years of age. An estimated 30,000 children below 15 years old develop MDR-TB each year, a condition challenging to treat with current medications due to numerous side effects. The associated treatment costs are burdensome for families and healthcare services.
Currently, less than 20% of children with MDR-TB receive diagnosis and treatment worldwide, rendering them one of the most neglected populations affected by TB. Many of these children have close contact with individuals carrying infectious MDR-TB. Identifying, screening, and providing preventive treatment to these children are crucial steps to both identifying more cases and preventing MDR-TB in children.
In December 2023, an advisory committee of the World Health Organization will review new guidelines for MDR-TB preventive treatment. Data from the TB-CHAMP and other trials are being shared to inform these deliberations and contribute to the formulation of new recommendations for children, adolescents, and adults. The TB-CHAMP trial, funded by Unitaid under the BENEFIT Kids project at Stellenbosch University, received support from various organizations, including the South African Medical Research Council, UKRI Medical Research Council, Department of Health and Social Care, Foreign, Commonwealth & Development Office, Global Challenges Research Fund, Medical Research Council, Wellcome, and the European Union through the EDCTP2 program.
