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

Institute of Tropical Medicine, Belgium

Status and phase: Withdrawn; Phase 3

Conditions: Tuberculosis, Pulmonary

Treatments: Drug: 6EHRZLfx; Drug: 6EHR³Z; Drug: 6EH³RZ

Study type: Interventional

Funder types: Other

Identifiers

NCT03862248

TriDoRe

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

High-Dose Isoniazid

Experimental group

Description:

New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg

Treatment:

Drug: 6EH³RZ

High-Dose Rifampicin

Experimental group

Description:

New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg

Treatment:

Drug: 6EHR³Z

World Health Organisation (WHO) regimen

Active Comparator group

Description:

WHO levofloxacin-strengthened regimen (6EHRZLfx)

Treatment:

Drug: 6EHRZLfx