International translational research from basic science to clinical trials
Medicine makes progress through testing new treatments in randomisied controlled clinical trials. The first such trial was performed by the Medical Research Council on a new tuberculosis medicine, streptomycin, in 1946. Today the Infection Group continue in that tradition using randomised controlled clinical trials to test new treatment regimens for tuberculosis. Our work is performed as part of international collaborations with trial sites and not-for-profit organisations such as the TB Alliance and PanACEA. Since the first of our trials REMoxTB we have participated in STAND, the optimisation of rifampicin dosage, PanACEA MAMS. The latest and ongoing trial is SimpliciTB, a phase 3 clinical trial evaluating the efficacy, safety, and tolerability of bedaquiline, pretomanid, moxifloxacin, and pyrazinamide (BPaMZ) containing regimens.
“Tuberculosis is a disease of poverty and a disease that makes people poor.”
Clinical Trials at St Andrews
The St Andrews TB research group has a history of conducting and participating in clinical trials at different levels. Our enthusiastic scientists have been making a contribution to ending TB via researching and testing novel pharmaceutical and innovative instrumental interventions to improve TB disease outcomes, diagnosis and treatment monitoring.
OptiRiMoxTB
OptiRiMox 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.
PanACEA
PanACEA (consortium) is an international tuberculosis research association which has, and continues to, perform a series of early phase trials. St Andrews leads on Microbiology, biomarkers and modelling and assists in trial design
REMoxTB
REMoxTB trial is a TB Alliance funded global Phase 3 clinical trial, conducted at 50 sites across 9 countries and is evaluating the treatment shortening efficacy of moxifloxacin based TB therapy from 6 months to 4 months.
SimpliciTB
SimpliciTB is a multi-centre phase 3 clinical trial evaluating a new shorter drug regimen (all-oral BPaMZ) in drug susceptible and resistant pulmonary tuberculosis across 4 continents led by TB Alliance.
STAND
STAND – Shortening Treatment by Advancing Novel Drugs, is a clinical trial assessing the efficacy, safety and tolerability of a novel combination of TB drugs in varying doses and treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB funded by TB Alliance.
TRiAD
TRiAD is a multi-centre, multi country study assessing the effectiveness, feasibility acceptability and cost-effectiveness of implementing a diagnostic technique for rapid selection of short drug-resistant tuberculosis. An additional aim is to implement the St Andrews Tuberculosis Molecular Bacterial Load Assay (MBLA) to assess the effectiveness of therapy in real time. The St Andrews team also provide Medical Monitoring to patients at 9 sites in 3 countries, Ethiopia, Nigeria & South Africa.
UNITE4TB
UNITE4TB is a seven year €185 million project. Thirty partners from 13 countries will deliver an efficient global clinical trials network equipped to implement phase 2 trials that conform to the highest regulatory standards. The goal is to deliver 2 novel phase 2 clinical trials to accelerate the development of new anti-tuberculosis drugs and regimens. The USTAN (University of St Andrews) group plays a key role in Work package 7 to develop definitions for biomarkers to monitor treatment effectiveness.