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

• Status: Withdrawn
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Tropical Medicine, Belgium
• Collaborator: Damien Foundation
• Treatments: Isoniazid; Rifampin

Criteria

Inclusion Criteria:

• All newly registered patients with smear-positive recurrent pulmonary TB

• Adults as well as children (no age limit)

• Able and willing to provide written informed consent

Exclusion Criteria:

• Patients transferred to a health facility not supported by Damien Foundation will be excluded. This includes patients diagnosed with HIV/TB-coinfection.