NCT03862248

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	6EH³RZ	New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg
DRUG	6EHR³Z	New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg
DRUG	6EHRZLfx	WHO levofloxacin-strengthened regimen (6EHRZLfx)

Timeline

• Start date: 2019-09-30
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2019-03-05
• Last updated: 2020-01-21

Locations

1 site across 1 country: Bangladesh