Hello, my name's Stephen Gillespie.
I'm the Sir James Black Professor of Medicine at the University of St. Andrews.
I'm going to talk today about the application of
whole genome sequencing in tuberculosis clinical trials.
In this talk, I will introduce the basic concepts of the tuberculosis clinical trial.
After providing a background of the evolution of
typing techniques apply to microbacteriology,
I will show the way in which
genome sequencing can assist in performing clinical trials better.
The areas covered will include defining relapse
and reinfection, detecting mixed infection,
using genomics to understand the significance of
post-treatment positives and conclude with some observations,
and how this exciting technology could be applied more widely in clinical trials.
This image represents the overview of the REMoxTB clinical trial,
the first of the modern-day studies using
regulatory methods and genomic techniques to contribute to the result.
Here you can see the treatment plans for the study
which compares the standard isoniazid, rifampicin,
ethambutol and pyrazinamide regimen with two experimental regimens that
substitute moxifloxacin and fluoroquinolones for either ethambutol or isoniazid.
The patients are treated for
four or six months and are followed for a year after the completion of treatment.
All of the patients had to be culture-positive to be included in the analysis.
In total, the patients attended 16 visits over their participation in the trial.
The isolates from patients who either failed on treatment or
had an apparent recurrence were collected as indicated.