OptiRiMoxTB (New)

This study is part of the  capacity development programme within SimpliciTB, and is sponsored and led by KIDH, Tanzania, managed by St Andrews, supported by UCL and Radboud UMC.  It is a pragmatic trial with optimized dose of rifampicin and moxifloxacin for the treatment of drug susceptible pulmonary tuberculosis (DS-TB) in primary care facilities in Blantyre, Malawi and across three other African countries namely Gabon, Mozambique, and Tanzania.

The trial is led by Kibong’oto Infectious Disease Hospital KIDH in Tanzania who are working with the University of St Andrews, Kamuzu University of Health Sciences KUHeS, Malawi, Centre de Recherches Médicales de Lambaréné CERMEL, Gabon and Instituto Nacionale De Saúde INS, Mozambique.

OptiRiMoxTB will establish whether a 4-month therapy based on rifampicin (35mg/kg) +/- Moxifloxacin (400 mg) is non-inferior to conventional 6-month DS-TB therapy.

The OptiRiMox study emerges from longstanding UStAn collaborations in Africa and our programme of tuberculosis drug development.

OptiRiMoxTB is funded by European & Developing Countries Clinical trials Partnership EDCTP and is part of a larger International clinical trial, SimpliciTB that provided funding for capacity development; objectives to extend and strengthen network of African clinical trial sites.  The University of St Andrews is coordinating and providing mentorship to the 4 recruiting sites in four countries, KIDH (Tanzania), CERMEL (Gabon), KUHeS (Malawi) and INS (Mozambique), along with Internationally experienced partners  TBAlliance, Radboud, UCL, TASK, NIMRMbeya.

The OptiRiMoxTB study will use the UStAn innovation: the TB-Molecular Bacterial Load Assay tool in the trial to measure treatment response.  This assay measures the number of TB bacteria in a patient sample in a matter of hours and monitors the effectiveness of medicine in killing the bacteria as treatment progresses and will be the used in the Trial.

Infrastructure support and a newly developed framework to measure and evaluate community engagement will also be used in the trial.

Tuberculosis causes about a million deaths every year. To change this and save lives, new tools, especially better treatments, are required.  Tuberculosis is preventable and treatable!