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Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More — TriDoRe  

Tuberculosis, Pulmonary Clinical Trial

Official title:
Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03862248
Study type Interventional
Source Institute of Tropical Medicine, Belgium
Contact
Status Withdrawn
Phase Phase 3
Start date September 30, 2019
Completion date October 1, 2022
View Details
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