November 25, 2023 Source: drugdu 129
Two landmark clinical trials involving researchers at University College London (UCL) have demonstrated that levofloxacin is the first effective treatment to prevent multidrug-resistant tuberculosis (MDR-TB).
Results from both trials were announced at the Union World Conference on Lung Health in Paris, France.
Annually, around 500,000 people develop tuberculosis (TB), an infectious disease caused by a type of bacteria that affects the lungs, that is resistant to multiple antibiotics.
Led by Stellenbosch University in South Africa, with the MRC Clinical Trials Unit (CTU) at UCL responsible for trial management and statistical analysis, the TB-CHAMP trial involved 922 children and adolescents exposed to an adult with MDR-TB in their household.
Results showed that levofloxacin reduced the risk of MDR-TB disease by 56%, with very few side effects reported.
Additionally, after one year, only 1.1% of children developed TB, compared to 2.6% who received a placebo.
The second trial, VQUIN, led by the Woolcock Institute of Medical Research and the University of Sydney, involved 2,041 adults and children living with a person with MDR-TB across ten provinces in Vietnam and revealed that levofloxacin reduced the risk of MDR-TB by 45%.
Levofloxacin is an antibiotic medication that is already approved to treat a number of bacterial infections, including respiratory tract infections, pneumonia and abdominal infections.
UCL researchers further analysed the data from both trials and confirmed that levofloxacin was safe and effective in preventing TB in both adults and children.
Using standard methods as well as a novel Bayesian approach developed by Becky Turner and professor Ian White from the MRC CTU at UCL, across both trials in total, levofloxacin reduced the risk of developing MDR-TB by 60%.
Trinh Duong, MRC CTU at UCL, TB-CHAMP trial statistician and lead for the combined analysis, said: “Combining data from two trial populations using novel methodology developed at UCL may pave the way for combining future paediatric and adult trial data.”
The MDR-TB preventative treatment is due to be considered by an advisory committee of the World Health Organization in December 2023 to consider new recommendations for children and adolescents.
https://www.pmlive.com/pharma_news/levofloxacin_revealed_as_first_effective_treatment_for_multi-drug_resistant_tb_1504145
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