OUR LATEST NEWS
OptiRiMoxTB – An international pragmatic trial with Optimised dose of Rifampicin and Moxifloxacin for the treatment of drug susceptible pulmonary tuberculosis (TB)
The OptiRiMoxTB clinical trial is part of SimpliciTB programme, which includes an international clinical trial and supports the development of capacity in the network of African clinical trial sites. The grant is funded by the EDCTP2 Programme (grant number RIA2017S-2012) .
The OptiRiMoxTB trial is being sponsored and led by the team at Kibong’oto Infectious Disease Hospital, KIDH in Tanzania. Prof.dr. Stella Mpagama is the Principal Investigator and a Senior EDCTP Fellow and honorary member of staff at the University of St Andrews. The KIDH and wider team are supported and mentored by University of St Andrews, who are also providing support to Mr Hamu Mlyuka (BPharm) an EDCTP Clinical Research and Product Development Fellow from Muhimbili University of Health and Allied Sciences, Tanzania also working for the trial. Long established partners, National Institute for Medical Research Mbeya Medical Research Centre, Mwanza Medical Research Centre, Kilimanjaro Clinical Research Institute and Ifakara Health Institute, Tanzania, University College London, Radboud University Medical Centre, Netherlands and TB Alliance are also supporting the sites.
The capacity development aspect of the trial aims to allow new TB trial sites so that they can perform therapeutic clinical trials. The new sites are Kamuzu University of Health Sciences KUHeS – Malawi, the Centres de Recherches Médicales de Lambaréné and the Instituto Nacional de Saúde, Mozambique.
OptiRiMoxTB is an important development that will test an easy to implement shorter regimen that emerges from our programme of research. It will test whether a 4-month therapy based on Rifampicin (35mg/kg) +/- Moxifloxacin (400mg) is non-inferior to conventional 6-month DS-TB therapy. It is anticipated the trial will recruit 414 patients.
All 4 trial sites are now recruiting participants, having successfully recruited 50% and are due to complete recruitment in August 2024. The sites have had many challenges to overcome throughout the clinical trial preparation phase.
If successful the OptiRiMoxTB regimen will allow individuals with-drug susceptible tuberculosis to be treated with well-established antibiotics in just four months, saving time money and reducing the burden on patients with this disease.
Lancet Publication
We are delighted to announce that our paper, resulting from the SimpliciTB Clinical Trial has been published in the lancet – you can read the full text here – https://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2824%2900223-8/fulltext
Clinical Trial Results Presented at CROI 2023
Clinical Trial for Drug-Sensitive and Drug-Resistant TB Regimen Evaluated Shorter Regimens
A clinician from the SimpliciTB trial in the Philippines preparing treatment for a clinical trial participant in 2019.
SEATTLE (February 20, 2023)—Results of TB Alliance’s SimpliciTB clinical trial were presented today at the 30th annual CROI 2023 conference. SimpliciTB was conducted to evaluate the BPaMZ regimen, consisting of bedaquiline (B), pretomanid (Pa), moxifloxacin (M), and pyrazinamide (Z). This combination previously showed high efficacy and treatment shortening potential in both preclinical evaluations and an early-stage clinical study in drug-resistant patients.
SimpliciTB enrolled 455 patients with drug-susceptible (DS) or drug-resistant (DR) tuberculosis (TB) at 26 sites across eight countries: South Africa, Tanzania, Georgia, Brazil, Russia, the Philippines, Uganda, and Malaysia.1 The clinical trial was designed to evaluate the safety and efficacy of BPaMZ in patients with either DS-TB or DR-TB. As presented at CROI, the results of the trial showed that the BPaMZ regimen was highly potent against the TB bacteria, meeting its primary endpoint with DS-TB participants 2.93 times more likely to culture convert by week 8. However, the 4-month experimental BPaMZ regimen did not meet the secondary endpoint of noninferiority in percent favorable outcomes compared to 6 months of HRZE in DS-TB. This was due to adherence challenges, with approximately 10% of patients on the BPaMZ arms discontinuing treatment due to side effects.1
“Innovative clinical trials like SimpliciTB help us better understand how novel drug regimens work against both drug-sensitive and drug-resistant TB, lighting the way to better treatment options for all people with TB,” said Dr. Muge Cevik, infectious diseases clinician and researcher at the University of St. Andrews and presenter of the SimpliciTB trial results at CROI 2023.
In 2021, 10 million people were infected with TB and about 1.6 million people died. It is estimated that about 500,000 people every year are infected by a drug-resistant form of the disease, and in some regions as many as 40% of all cases are drug-resistant.2 Novel drug regimens are urgently needed to help bring the TB pandemic under control.
TB Alliance plans to submit data from SimpliciTB to a peer-reviewed publication – https://www.tballiance.org.za/news/tballiance-simplicitb-results-croi-2023
Professor Stephen Gillespie
Professor Stephen Gillespie spoke at the UNITE4TB Webinar which took place on 8th June. He summarised the current role of biomarkers in TB treatment and clinical trials. Explaining the concept of microbiological biomarkers, highlighting the current gold standard techniques (liquid and solid mycobacterial culture), and demonstrated the challenges posed. He also gave an overview of the most important TB biomarkers under evaluation.
A link can be found on this page https://www.unite4tb.org/newsroom/unite4tb-webinar-recap-expert-interview-biomarkers-tb-clinical-trials to hear the full webinar recording.
A Webinar for Frontiers in Antibiotics on the subject of “Antibiotic Drug Development- Refilling the Pipeline” was also hosted and convened by Professor Gillespie. Speaking at the Webinar were Dr Derek Sloan and Dr Robert Hammond. Here is the link to the seminar: Refilling the Antibiotic Pipeline – Webinar By Frontiers in Antibiotics https://youtu.be/X-6lP64B7eY
Professor Gillespie also participated as a board member for the most recent Medical Research Council African Leaders Scheme grant call and was an invited participant in the Wellcome Trust/University of Liverpool Witness Seminar on the “Organisation of Public Health Microbiology”.