Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More
Status:
Withdrawn
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Drug-resistance is a major challenge for tuberculosis (TB) care programs. The new WHO
guideline recommends adding levofloxacin in previously treated patients with
isoniazid-resistant rifampicin-susceptible TB. The investigators believe that such a
retreatment regimen may result in acquired resistance to fluoroquinolone, the core drug of
multidrug-resistant TB (MDR-TB) regimen, and thus threaten the effectiveness of the
fluoroquinolone-based MDR-TB treatment regimen. Therefore the investigators propose to study
if regimens strengthened by using high-dose first-line drugs, either a triple dose of
isoniazid or a triple dose of rifampicin, are non-inferior to the WHO recommended
levofloxacin-strengthened regimen. If one of both high-dose regimens would be non-inferior,
it could replace the levofloxacin-strengthened regimen.