Project Title: A pragmatic trial with optimized dose of rifampicin and moxifloxacin for the treatment of drug susceptible pulmonary tuberculosis
Project Description: The OptiRiMoxTB trial will be conducted at clinical study sites in Gabon, Malawi, Mozambique, and Tanzania; all LMICs with a high TB incidence, including cases amongst people who are living with Human Immunodeficiency Virus (HIV) (1). It will be sponsored, and led, from Kibong’oto Infectious Diseases Hospital (KIDH) in Tanzania. In Tanzania, the study will be conducted at the Kibong’oto Infectious Diseases Hospital (KIDH), Ifakara Health Institute (IHI) and the National Institute of Medical Research... The OptiRiMoxTB trial will be conducted at clinical study sites in Gabon, Malawi, Mozambique, and Tanzania; all LMICs with a high TB incidence, including cases amongst people who are living with Human Immunodeficiency Virus (HIV) (1). It will be sponsored, and led, from Kibong’oto Infectious Diseases Hospital (KIDH) in Tanzania. In Tanzania, the study will be conducted at the Kibong’oto Infectious Diseases Hospital (KIDH), Ifakara Health Institute (IHI) and the National Institute of Medical Research – Mwanza (NIMR-MWANZA). The duration is 30 months. 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. By design, this is a pragmatic phase III multi-centre, open label, randomised controlled clinical trial. A total of up to 414 adult (≥ 18 years of age) patients will be randomly allocated to the 26-week control or one of two 16-week experimental regimens in the ratio 1:1:1. The OptiRiMoxTB trial has been specifically designed to strengthen and expand clinical trial capacity in four African countries, using PanACEA and SimpliciTB affiliated sites. Drugs to be administered during this study include the following: rifampicin, moxifloxacin, isoniazid, pyraziminade, and ethambutol. Decisions on medical care of study participants within the trial shall be the responsibility of the site Investigator. Study drugs will be handled, stored and distributed in accordance with the Drug Management Plan, which will be completed before study initiation. Irrespective of the final trial results, study participants will also benefit from clinical care by dedicated study teams who will be trained to monitor treatment response and manage any problems which arise. It will also benefit society by contributing to our collective understanding of optimal strategies for treating tuberculosis. The deliberate capacity building focus across all study sites, will be beneficial in improving TB clinical trials infrastructure across Africa. Participant compensation: Trial participants will receive a flat sum per trial visit for out-of-pocket expenses, which covers loss of salary, travel to/from site and other miscellaneous cost, depending on the judgement and approval of the site’s ethics committee. All information from paper CRFs will be entered into the Research Electronic Data Capture (REDCap) study database within 7 days of receipt, using double data entry. All essential documentation should be retained until the sponsor gives notice, not less than 10 years after the end of the study. All participant records, laboratory specimens etc. will be identified in appropriate manner to maintain participant confidentiality and will be kept in a secure storage area with limited access
Principal Investigator : Beno Mbeya
Department Name :
Time frame: (2024-02-24) - (2025-10-31)
The University Court of The University of St Andrews (Normal)
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