New hope against Drug-Resistant TB: phase II trial launches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 14 to \< 65 years, male or female * Confirmed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) by molecular testing (e.g., Xpert MTB/RIF) or drug susceptibility testing * Positive sputum culture for Mycobacterium tuberculosis or positive molecular test * Chest imaging consistent with active pulmonary TB, or histologically confirmed extrapulmonary TB (excluding CNS, osteoarticular, and disseminated TB) * Body weight ≥ 40 kg * Karnofsky Performance Status ≥ 50 * Adequate laboratory parameters: * Hemoglobin ≥ 8.0 g/dL * ANC ≥ 1000/mm³ * Platelets ≥ 75,000/mm³ * ALT/AST ≤ 3 × ULN * Total bilirubin ≤ 2 × ULN * Creatinine clearance ≥ 30 mL/min * QTcF interval \< 450 ms (male) or \< 470 ms (female) * HIV-negative, confirmed by approved testing * No prior exposure to bedaquiline, delamanid, or linezolid for more than 1 month * Female participants of childbearing potential must agree to use effective contraception and have a negative pregnancy test * Signed informed consent Exclusion Criteria: * Central nervous system TB (e.g., TB meningitis), osteoarticular TB, or disseminated/miliary TB * Known allergy or serious adverse reaction to any study drug or background regimen component * Known resistance to bedaquiline, delamanid, or linezolid * Use of anti-TB drugs within the past 30 days that may interfere with study assessments, except in documented treatment failure cases * Severe comorbidities, including: * NYHA Class III-IV heart failure * History or risk factors for Torsades de Pointes * Child-Pugh B or C cirrhosis * Uncontrolled diabetes (HbA1c \> 10%) * Active malignancy * Current use of QT-prolonging medications that cannot be substituted * Current use of MAO inhibitors or serotonergic drugs * BMI \< 17 kg/m² with severe malnutrition * Grade 3-4 peripheral neuropathy at baseline * Pregnant or breastfeeding women * Any condition that, in the investigator's judgment, may interfere with study completion or data interpretation