Description:
A phase II, prospective, randomized, two-arm, open-label, multicenter clinical trial to evaluate the anti-tuberculosis (TB) activity, safety, and tolerability of an injectable-free short course regimen for treatment of multidrug-/rifampicin-resistant (MDR-/RR-), pre-extensively drug-resistant (pre-XDR-), and extensively drug-resistant (XDR-) TB comparing two dosing strategies of linezolid (LZD) combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ).
Start Date: May 21, 2019
Eligibility:
Participants aged 18 years and older, with or without HIV, with newly diagnosed pulmonary MDR/RR-TB, pre-XDR-TB, or XDR-TB (collectively noted as DR-TB in the protocol).
Participants living with HIV are required to either be on ART or be willing to start ART within 30 days after entry.
Participants may be enrolled with a positive rapid diagnostic test for MDR/RR-TB such as Cepheid Xpert MTB/RIF, Cepheid Xpert MTB/RIF Ultra, Hain GenoType MTBDRplus, Hain GenoType MTBDRsl, or other World Health Organization (WHO)-endorsed rapid diagnostic test or with screening phenotypic drug susceptibility testing (DST) from a sputum specimen collected within 60 days prior to entry.
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