Masterarbeit

Today's regulatory strategies and clinical approaches for the development of treatment regimens for active MDR-TB

Iris Fichert (2019)

Summary
Language: English
Robert Koch announced 1882 the discovery of the tubercle bacillus as causative agent of tuberculosis, a chronic infectious disease mostly affecting the lungs. In 1943 streptomycin, the first active compound against Mycobacterium tuberculosis was discovered. In 2018 about 130 years later TB is the leading cause of death from a single infectious agent worldwide, ranking above HIV. Major concern does exist about the development of multidrug-resistant TB (MDR-TB). The treatment of MDR-TB is burdensome for patients due to combinations of less effective and less tolerable second-line drugs including injectables, which have to be given over months. This is one factor contributing to the weak treatment outcomes for MDR-TB. From estimated half a million patients infected with MDR-TB only 14% were estimated to be successfully treated in 2017. The first randomised clinical trial on MDR-TB was conducted in 2012 and some promising progress has been made since that time, but still further progress is needed for a shorter, less toxic and more effective treatment regimen to combat MDR-TB.
The present master thesis gives an overview on the current MDR-TB crisis and discusses today’s approaches and challenges in the clinical development of treatment regimens consisting of a combination of drugs for MDR-TB as well as regulatory strategies supporting this development.
Pages: 60