PhD upgrade | The population pharmacokinetics and pharmacodynamics of investigational regimens’ drugs in the TB-PRACTECAL trial

Summary

Tuberculosis infects a quarter of the world’s population, causing disease in over 10 million people annually. It causes death in 1.7 million people per year putting it above HIV/AIDS as the number one killer from a single agent in the world. Rifampicin resistant/multidrug resistant-TB (RR-/MDR-TB) poses a major threat to the progress being made in global TB control. RR-/MDR-TB is treated using second line drugs.

There is limited data published on the pharmacokinetics and pharmacodynamics of the second line anti-TB drugs. We plan therefore to conduct a population pharmacokinetics and pharmacodynamics study nested in the TB-PRACTECAL trial. TB-PRACTECAL is a multicentre, open label, phase 2-3 randomised controlled trial evaluating 6 months, exclusively oral regimens containing bedaquiline, pretomanid, linezolid +/- moxifloxacin or clofazimine for the treatment of microbiologically confirmed pulmonary M/XDR-TB. Our primary objective is to measure the plasma concentrations of the above drugs in a subset of patients in the TB-PRACTECAL trial and using non- linear mixed effects methods to estimate the population drug exposure metrics.

The study and PhD are funded by Médecins sans Frontières.

Details

Speaker: Bern-Thomas Nyang’wa

Date: 9 March 2018

Time: 12:45 – 14:00

Venue: LG6, Keppel Street

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