NCT05575518

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Stellah Mpagama · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study objectives of this clinical trial are Primary effectiveness objective: To evaluate whether one or both of two experimental regimens based on optimised dose rifampicin with or without moxifloxacin and given for 16 weeks are non-inferior to standard treatment for drug-susceptible tuberculosis given for 26 weeks, as assessed by patient survival, free of tuberculosis 12 months after initiation of therapy. Primary safety objective: To evaluate whether one or both of two experimental regimens based on optimised dose rifampicin with or without moxifloxacin and given for 16 weeks are as safe and tolerable as standard treatment for drug-susceptible tuberculosis given for 26 weeks, as assessed by the frequency of Adverse Events (AEs) of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 severity or higher. Participants will be individuals with bacteriological confirmed pulmonary TB aged 18 years or above, with or without HIV co-infection in Gabon, Malawi, Mozambique and Tanzania. The trial sites are also established members of the PanACEA / SimpliciTB group including the Centre de Recherches Médicales de Lambaréné (CERMEL)-Gabon, the Helse Nord Tuberculosis Initiative (HNTI) at Kamuzu University of Health Sciences (KUHES)-Malawi and the Polana Caniço Health Research and Training Center (CISPOC) at the Instituto Nacional de Saúde (INS)-Mozambique and the Kibong'oto Infectious Diseases Hospital-Tanzania.

Conditions

• Tuberculosis
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Optimised rifamycin	optimised dose rifampicin with or without moxifloxacin

Timeline

• Start date: 2023-08-11
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2022-10-12
• Last updated: 2023-08-25

Locations

1 site across 1 country: Tanzania