Medical Research: What are the main findings of the study?
Dr. Gillespie: REMox TB was a pioneering trial that has shown that a large-scale trial can be run efficiently in resource-poor settings with a high TB burden, adhere to the highest standards of good clinical trial practices, and deliver a clear, unequivocal result. REMoxTB was among the most rigorous Tuberculosis drug trials ever conducted in the modern era of TB treatment and among the largest ever conducted for a new TB treatment. It enrolled 1,931 patients at 50 sites in nine countries, mostly in Africa and Asia. Previously, there were thought to be regional differences in way in which patients’ response to treatment across the world but we showed that a rigorous approach to trial conduct there was no evidence for that difference.
The study confirmed that daily moxifloxacin was safe over four months of therapy and the moxifloxacin containing arms were more bactericidal initially. Despite its substantial anti-TB activity it did not prove possible to shorten therapy to four months. .
These findings, with the safety of moxifloxacin, and its activity against TB, support the continued clinical testing of moxifloxacin as a component of other novel regimens.
Medical Research: Were any of the findings unexpected?
Dr. Gillespie: We undertake clinical trials because we don’t know the answer. What might have been unexpected is that a trial of this scope and rigor could be conducted or completed. We have shown that it is possible to conduct high quality clinical trials for new Tuberculosis treatments using state of the art diagnostic methods in countries that have a high TB burden. More importantly, it is possible for clinicians and scientists in resource-poor nations to play a critical role in finding innovative solutions to this disease.
Medical Research: What should clinicians and patients take away from your report?
Dr. Gillespie: Our report shows that moxifloxacin is safe over extended periods for tuberculosis and that it is likely to be the cornerstone of a new regimen. It also shows that finding a better regimen is challenging, but when clinicians, scientists and health professionals across the world work together much can be achieved as REMoxTB has brought a four month regimen closer to reality.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Gillespie: REMoxTB paved the way for future progress by showing us that effective, markedly shorter and safer treatments are just within our grasp. It is likely that we will need to build novel regimens that combine multiple novel agents to make a more bactericidal regimen. Moxifloxacin most certainly looks like it can play a role in such future treatments.