An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis
Status:
Completed
Trial end date:
2021-08-30
Target enrollment:
Participant gender:
Summary
This study aims to evaluate the impact of a new injection-free six-to-nine month treatment
regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose
isoniazid (INH) compared to the conventional empiric injection-based regimen. The secondary
aim is to determine if other treatment-related outcomes including adverse events, adherence
to treatment, culture conversion, and cure/completion are significantly different in the
intervention and conventional arms.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Cape Town
Collaborators:
University of Cape Town Lung Institute University of Limpopo University of Stellenbosch Walter Sisulu University