A Phase 3 interventional study of Optimised rifamycin in Tuberculosis and Human Immunodeficiency Virus, sponsored by Stellah Mpagama. Recruiting at 1 site in Tanzania. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Stellah Mpagama · Phase 3, Interventional, and Treatment
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.
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 414 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →This is the only study on the registry with Stellah Mpagama as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Each patient must meet all the following inclusion criteria prior to enrolment into the trial:
The patient has a diagnosis of pulmonary TB established by Xpert MTB/RIF® result which confirms "low" "medium" or "high" level detection of M tuberculosis and does not detect rifampicin resistance.
Exclusion Criteria:
Patients for whom one of the following criteria is met will be excluded from the trial:
Standard of care according to the National TB Programmes which is a weight-banded rifampicin, isoniazid, pyrazinamide, and ethambutol for weeks 0-8 followed by rifampicin and isoniazid for weeks 9-26.
Optimised dose of rifampicin. The rifampicin 35mg/kg alongside standard weight-banded doses of isoniazid, pyrazinamide, and ethambutol, once daily
Drug: Optimised rifamycin
Optimised dose of rifampicin and moxifloxacin. The rifampicin 35mg/kg and moxifloxacin 400mg alongside standard weight-banded doses of isoniazid and pyrazinamide, once daily.
Drug: Optimised rifamycin
optimised dose rifampicin with or without moxifloxacin
Also known as: 8-methoxy-fluoroquinolone
Bacteriological cure, absence of either TB treatment failure or relapse
Treatment failure, defined as submitting two sputum samples with positive culture for M tuberculosis on different visits, when the first of these samples was collected at or after two weeks prior to the scheduled end of treatment. TB relapse, defined as submitting two sputum samples with positive culture for M tuberculosis on different visits, when the first of these samples was collected after completion of scheduled TB therapy and where at least one of the M tuberculosis isolates is genetically similar to the baseline strain.
Time frame: Participant survival, free of tuberculosis 12 months after randomisation
Proportional of adverse events (AE) of grade 3 severity or higher
The severity of all AEs will be classified according to the U.S. National Institutes of Health Common Terminology Criteria for Adverse Events 5.0 (CTCAE).
Time frame: 4 or 6 months of treatment
Proportional of clinically significant adverse events related to the intervention
Treatment discontinuation or interruption related to AE
Time frame: 4 or 6 months of treatment
Clinical improvement of TB symptoms
Clinical response of TB symptoms as measured by questionnaire
Time frame: 12 month after randomisation
Clinical improvement of body mass index (BMI)
Increase of BMI as measured by the ratio of weight (kg) and height squared in metres squared
Time frame: 12 month after randomisation
Clinical improvement of participant reported health status
Increase of participant reported health status as measured by questionnaire
Time frame: 12 month after randomisation
Participant survival free of TB
Recurrent of symptoms and bacteriological confirmation of TB
Time frame: 12 months after completing TB treatment
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