Research news
Antibiotic treatment for drug-resistant tuberculosis found to be safe and effective: clinical trial
Jan 24 2025
Levofloxacin substantially reduces risk of drug-resistant tuberculosis, researchers in Australia have found
Clinical trial results published in the New England Journal of Medicine have shown that levofloxacin, an oral antibiotic, taken once-daily for six months cut the risk substantially of developing drug-resistant tuberculosis (TB). The rate was almost halved in both adults and children of developing multidrug-resistant TB.
“Multidrug-resistant TB is a major global public health problem which affects more than 400,000 people each year,” said Professor Gregory Fox, Director of the NHMRC Centre for Research Excellence in Tuberculosis and who led the VQUIN trial at the University of Sydney’s Woolcock Institute of Medical Research in collaboration with the Vietnam Tuberculosis Programme.
“We have now found a way of stopping people with early TB infection from becoming sick and spreading infection to other people,” he said.
The study was conducted across 10 provinces in Vietnam, a country which has a high rate of drug-resistant TB. The clinical trial enrolled 2,041 family members of people with drug-resistant TB. The study participants had an early infection which had not developed into the active form of drug-resistant TB.
The trial found that levofloxacin reduced the risk of multidrug-resistant TB (MDR-TB) in adults and adolescents by 45 percent. The trial findings were combined with a second trial, TB-CHAMP, that took place in South Africa and involved the same treatment in children. Together, the two studies demonstrated that levofloxacin could significantly reduce the risk of MDR-TB among family and other household members. The combined analysis was published on the same day in the companion journal NEJM Evidence.
Evidence to date has been limited on MDR-TB preventive treatment since no randomised controlled trials had been conducted prior to the VQUIN study.
“The VQUIN trial is a major step forward in the fight against drug-resistant TB.
“This evidence changes the way we care for people at risk of drug-resistant TB globally. The benefits to the families and communities at risk of MDR TB is substantial,” said Professor Fox.
In the trial, 2,041 adults and children living with a person who had MDR-TB in the same household were given six months of levofloxacin and monitored for 30 months. The study found that there were 45 percent fewer cases of TB in the group given levofloxacin compared to the placebo group. Levofloxacin was found to be safe and well-tolerated in adults and children. Also, notably, a lower number of cases of TB occurred in the placebo group than would have been expected.
In September 2024, the World Health Organisation issued new guidelines for MDR-TB preventive therapy. The guidelines were based on the initial findings of the VQUIN trial.
The trial also completed work on other important considerations such as acceptability of the drug regimen, feasibility, health economics, pharmacokinetics and antimicrobial resistance.
The teams from the VQUIN trial in Australia and TB CHAMP trial in South Africa collaborated before the trials were unblinded. They combined their data on efficacy and safety in traditional and novel Bayesian approaches. Jointly, they showed that across both trials, levofloxacin reduced the risk of developing TB by 60 percent. Novel Bayesian analysis showed similar results for each trial, individually.
For further reading please visit: 10.1056/NEJMoa231432
Digital Edition
Lab Asia 32.1 Feb 2025
February 2025
Chromatography Articles - Comparing volumetric and thermal flowmeters for assessing and validating liquid chromatography performance Mass Spectrometry & Spectroscopy Articles - The importa...
View all digital editions
Events
SPS Smart Production Solutions Guangzhou
Feb 25 2025 Guanghzou, China
Feb 25 2025 Amsterdam, Netherlands
Feb 27 2025 Kathmandu, Nepal
Mar 01 2025 Boston, MA, USA
Mar 02 2025 Bethesda, MD, USA