Strengthening Clinical trial Capacity Development in Tanzania, Malawi, Gabon & Mozambique
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. 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 Dr Hamu Mlyuka 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 Kamazu University of Health Sciences KUHeS, Malawi, Centres de Recherches Médicales de Lambaréné De Saúde, INS, 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 over 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.