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Clinical trial

An Open Label, Randomized Controlled Trial to Establish the Efficacy and Safety of a Study Strategy Consisting of 6 Months of Bedaquiline (BDQ), Delamanid (DLM), and Linezolid (LNZ), With Levofloxacin (LVX) and Clofazimine (CFZ) Compared to the Current South African Standard of Care (Control Strategy) for 9 Months for the Treatment of Rifampicin Resistant Tuberculosis (RR-TB)

NCT04062201 is registered in ClinicalTrials.gov with Wits Health Consortium (Pty) Ltd as lead sponsor.

NCT NCT04062201
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open Label, Randomized Controlled Trial to Establish the Efficacy and Safety of a Study Strategy Consisting of 6 Months of Bedaquiline (BDQ), Delamanid (DLM), and Linezolid (LNZ), With Levofloxacin (LVX) and Clofazimine (CFZ) Compared to the Current South African Standard of Care (Control Strategy) for 9 Months for the Treatment of Rifampicin Resistant Tuberculosis (RR-TB)
Lead sponsor
Wits Health Consortium (Pty) Ltd
Phase
Phase 3
Overall status
Completed
Start date
August 22, 2019
Completion date
April 15, 2024
Enrollment
402 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

extensively drug-resistant tuberculosis, multi drug resistant tuberculosis, pre-xdr-tb, rifampicin resistant tuberculosis, tuberculosis