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Two groundbreaking clinical trials reported Trade union conference in Paris showed that taking oral antibiotics once a day for 6 months significantly reduced the risk of developing drug-resistant tuberculosis.
The antibiotic levofloxacin safely reduces the risk of multidrug-resistant (MDR) tuberculosis (TB) disease in children by 56%, researchers from the Desmond Tutu Tuberculosis Center at Stellenbosch University told a coalition meeting in Paris today. announced that it had. The trial also showed that levofloxacin, given once daily, is extremely safe for children over 6 months of age.
A second study, the VQUIN study, was also presented at the same session. The VQUIN trial was conducted primarily in adults and adolescents and found that levofloxacin reduced the risk of MDR-TB in adults and adolescents by 45%. Taken together, the two studies demonstrate that levofloxacin can stop the risk of MDR-TB in family members and other household members and limit the global impact of this dangerous pathogen.
Evidence regarding preventive treatments for MDR-TB is limited to date, as no randomized controlled trials have been conducted to date. TB-CHAMP serves communities with a high burden of tuberculosis and multidrug-resistant tuberculosis, with a primary focus on children under the age of five, at his six research sites in five provinces in South Africa. It was provided and held.
“Although there have been many advances in the science of preventing drug-susceptible TB, there is little hard data on preventing drug-resistant TB,” said Anneke, Director of the Desmond Tutu Tuberculosis Center and Principal Investigator for Overall TB. Professor Hesseling said. CHAMP exam at Stellenbosch University.
“We have discovered a way to safely protect children when an adult in the household has multidrug-resistant tuberculosis. Underestimating the importance of protecting children from drug-resistant disease The benefits for children, their families and communities could be significant.”
“MDR-TB is one of the most difficult diseases to treat and children have always been the most neglected patients,” said Professor James Seddon, co-principal investigator of TB-CHAMP at Stellenbosch University. .
“By finding new ways to keep children safe when a family member is affected by MDR-TB, we can help reduce the impact of this disease, not just from a health perspective, but also from an economic and mental health perspective. We help the whole family recover faster from the trauma inflicted on them. The same way.”
“More than 450,000 people develop multidrug-resistant tuberculosis every year. Drug-resistant tuberculosis can have a devastating impact on patients and their families,” says the Woolcock Institute of Medical Research and the University of Sydney’s VQUIN study. said Professor Greg Fox, lead researcher. .
“There is now evidence that people who are infected early can prevent disease from drug-resistant tuberculosis. This once-daily treatment for six months can protect adults, children, adolescents, and infants from developing tuberculosis. We can protect against the physical, social and economic consequences of drug-resistant tuberculosis.”
“Research into the prevention and treatment of childhood tuberculosis has been on the back burner for far too long,” said Dr. Philippe Duneton, executive director of Unitaid, the world’s largest multilateral funder of tuberculosis research and development.
“Unitide is pleased to be part of this effort to advance the needs of children. This first-of-its-kind evidence for the prevention of drug-resistant tuberculosis in children will save millions of children from this debilitating disease. This is a huge advance that has the potential to protect us.”
In the TB-CHAMP trial, 453 children who had household contact with an adult with MDR-TB were given levofloxacin, and only five developed MDR-TB. There were almost no side effects from the drug. In particular, the traditional concerns of joint pain and tendonitis were extremely rare in children receiving levofloxacin.
In the VQUIN study, 2,041 adults and children living with someone in their household who had MDR-TB were given levofloxacin for 6 months and followed for 30 months. The study was conducted in 10 provinces across Vietnam. The results showed that the group receiving levofloxacin had 45% fewer cases of tuberculosis compared to the placebo group. The number of tuberculosis cases that occurred in the placebo group was lower than expected. Overall, levofloxacin was found to be safe and well tolerated in adults and children.
Tuberculosis remains one of the leading causes of death in children worldwide and one of the leading killers of children under the age of five. Each year, an estimated 30,000 children under the age of 15 develop MDR-TB disease. MDR-TB disease has many side effects and is difficult to treat with current drugs. Treatment costs are high for both families and health services.
Currently, less than 20% of children worldwide are diagnosed with and treated for multidrug-resistant tuberculosis. This makes them one of the most neglected populations affected by tuberculosis worldwide. Many of these children have close contact with infectious multidrug-resistant tuberculosis patients, and identifying these children, screening them for tuberculosis, and providing preventive treatment could reduce more cases. This will be critical to discovering and preventing multidrug-resistant tuberculosis in children.
In December 2023, a World Health Organization advisory committee will consider new guidelines for preventive treatment of multidrug-resistant tuberculosis. Data from the TB-CHAMP and VQUIN trials are being shared to inform how these deliberations will generate new recommendations for children and adolescents. The TB-CHAMP and VQUIN trials also completed work on other important considerations, including regimen acceptability, feasibility, health economics, pharmacokinetics, and antimicrobial resistance.
The TB-CHAMP and VQUIN trial teams collaborated early on, before the trials were blinded, to combine efficacy and safety data with traditional and novel Bayesian approaches. Together, they showed that across both trials, levofloxacin reduced the risk of developing tuberculosis by 60%. A new Bayesian analysis showed similar results for each trial individually.
“This new Bayesian analysis combines data from trials in two trial populations using new methodology developed at the MRC CTU at UCL, and combines future pediatric and adult trial data to This could pave the way for ensuring that no one is left behind,” said Trinh Duong. TB-CHAMP trial statistician and head of combined analysis in her MRC clinical trials unit at UCL.
“Careful planning in advance of this study will allow us to present these important findings alongside the main results of the two trials, which could have a significant impact on global guidelines and policy. .”
Provided by Stellenbosch University, South Africa