A landmark clinical trial reported last week at the Union Conference on Lung Health in Paris meeting showed that an oral antibiotic taken for six months once-daily substantially reduced the risk of developing drug-resistant TB. The antibiotic levofloxacin safely reduced the risk of multidrug-resistant (MDR) tuberculosis (TB) disease in children by 56%, researchers from the Desmond Tutu TB Centre at Stellenbosch University's Faculty of Medicine and Health Sciences (FMHS) announced. The Unitaid-funded trial also showed that levofloxacin given once daily to children over six months, was extremely safe.
Evidence to date has been limited about MDR-TB preventive treatment since no randomized controlled trials had ever been conducted. TB-CHAMP took place in South Africa, in six research sites in five provinces serving communities with high burdens of TB and MDR-TB, focusing mainly on children below five years of age.
“There have been many advancements in the science around preventing drug-susceptible TB, but very little rigorous data on preventing drug-resistant TB," said Professor Anneke Hesseling, Director of the Desmond Tutu TB Centre and the overall Principal Investigator of the TB-CHAMP trial, at Stellenbosch University. “We have now found a way to safely protect children when an adult in the household has MDR-TB. The importance of safeguarding our children from drug-resistant disease cannot be underestimated. The benefit to children, their families and communities may be substantial."
“MDR-TB is one of the toughest diseases to cure, and children have always been the most neglected patients," said Professor James Seddon, 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," said Dr Philippe Duneton, Executive Director of Unitaid, the largest multilateral funder of TB research and development globally. “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 MDR-TB in their household were given levofloxacin and only 5 developed MDR-TB. There were very few side events from the medicine. Specifically joint pain and tendonitis, traditionally a concern, were very uncommon in children receiving levofloxacin.
TB remains one of the top causes of death in children globally and is a one of the top killers of children below 5 years of age. An estimated 30 000 children below 15 years of age develop MDR-TB disease each year, which is complex to treat with current medications, which have many side effects. The cost of treatment is high to families and to health services.
Fewer than 20% of children with MDR-TB are currently diagnosed and treated globally. This makes them one of the most neglected populations affected by TB. Many of these children were in close contact with someone with infectious MDR-TB and identifying these children, screening them for TB and offering preventive treatment will be critical to find more cases and also to prevent MDR-TB in children.
In December 2023, an advisory committee of the World Health Organization will consider new guidelines for MDR-TB preventive treatment. The data from the TB-CHAMP and other trials is being shared to inform how these deliberations produce new recommendations for children, adolescents and adults. The TB-CHAMP trial was funded by Unitaid, under the BENEFIT Kids project at Stellenbosch University. Unitaid accelerates access to innovative health products and lays the foundations for their scale-up by countries and partners. The trial was also funded by the South African Medical Research Council and the UKRI Medical Research Council through a trial grant to Stellenbosch University, with support from the Department of Health and Social Care, the Foreign, Commonwealth & Development Office, the Global Challenges Research Fund, the Medical Research Council and Wellcome, as part of the EDCTP2 programme supported by the European Union.
Media contact: Marina Carter