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.
Our Mission
Globally, tuberculosis (TB) is the leading cause of death from a single infectious disease agent. In 2021 an estimated 1.5 million people died of TB which has meant a significant rise in mortality compared to previous years.
Together with our international partners, the TB research team at the University of St Andrews is fighting the global pandemic of TB by testing and implementing innovative treatments and developing novel diagnostic and treatment monitoring tools. Our sustained research over the last 11 years (on the disease and pathogen responsible) has developed global capacity to improve TB treatment and understanding of the disease.
Tuberculosis diagnosis is an important target of our research as the current tools are slow takins as much as three months to be able to tell a patients whether they have TB or not or how their ongoing disease is progressing. We have developed new tuberculosis diagnostic tests that makes the diagnosis real-time and can also quantify the number of live bacteria so that treatment can be started quickly and the response to it measured rapidly.
We are also proud partners of many global organisations and consortia such as PanACEA, TB Alliance and UNITE4TB sharing the vision of a TB free world. The immense experience of our academic scientific team in clinical trials have been contributing to the realisation of our goals.
Our Impact
Our scientific group is undertaking cutting-edge laboratory and clinical research making an impactful contribution to the global fight against the TB pandemic.
The research we carry out has led to the evaluation of new TB treatment and the delivery of new tools for infection control.
Over the past decade we have been in the core of many international consortia, academic research and clinical studies bringing innovation to the field of TB biomarker, diagnostics and treatment strategies.
From 2008 we have been members of the PanACEA network facilitating the collaboration with many African research laboratories, hospitals and universities advancing TB diagnosis, treatment and treatment response monitoring. This research has ultimately led to the development and commercialization of an assay for real-time detection of TB bacterial load and the patients’ response to therapy.
“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.
POA is a Phase III parallel‑group, open‑label, multi‑country, multi‑centre randomised controlled trial evaluating a new once‑weekly oral long‑acting antiretroviral regimen to determine whether it maintains viral suppression as effectively as daily therapy. The trial is coordinated by the University of St Andrews, with support from the University of Liverpool and Università degli Studi di Torino, and is being conducted in Uganda, Kenya, Côte d’Ivoire, and Zimbabwe to compare this regimen with standard first‑line treatment in adults who are already virologically suppressed. Feasibility, safety, and cost‑effectiveness will also be assessed to inform potential integration of this regimen into routine HIV care.
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.
UNITE4TB is a seven year €185 million project. Thirty partners from 13 countries will deliver an efficient global clinical trails 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.
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.
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.
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 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.
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.