A Pragmatic Trial With Optimized Dose of Rifampicin and Moxifloxacin for the Treatment of Drug Susceptible Pulmonary Tuberculosis

• Status: Not yet recruiting
• Trial end date: 2026-03-31

Summary

Tuberculosis (TB) remains a major global public health problem, particularly in low- and middle-income countries (LMICs) in Africa, Asia, and Eastern Europe. Approximately 10 million people fall sick with TB, causing up to 2 million deaths, worldwide per year. Considerable progress was made in TB control from 1990-2015, motivating the World Health Organization (WHO) to launch an ambitious EndTB strategy. However, the effect of the ongoing Coronavirus Disease 2019 (Covid-19) pandemic has been devastating and the last two years have seen the first year-on-year increases (of 5.6%) in TB mortality since 2005 . In order to regain lost ground, and re-establish progress towards elimination of TB, innovation is needed in all aspects of TB control, including development of shorter treatment regimens for drug susceptible (DS) and multi-drug resistant / rifampicin resistant (MDR/RR) forms of the disease.

This protocol seeks to conduct the TB clinical trial combining the 8-methoxyfluroquinolone and optimised dose of rifamycing to address two questions. The first is to confirm the non-inferiority of a four-month optimised dose rifamycin and moxifloxacin-based regimen amongst African TB patient populations with high rates of co-incident HIV. Secondly, we seek to establish that the rifamycin of choice in potent 4-month anti-TB treatments could be rifampicin as this will be more rapidly up-scalable for public health impact.

• Phase: Phase 3

Details

• Lead Sponsor: Stellah Mpagama
• Collaborators: Radboud University Medical Center; University of St Andrews
• Treatments: Fluoroquinolones; Rifamycins