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

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.