Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan

Exclusion Criteria

• •Baseline contraindications to any medications of the study regimen medications, where benefits of the regimen do not outweigh the risks as judged by treating physician;
• •Severe renal insufficiency with estimated creatinine clearance of \<30 ml/min at baseline (calculated with Cockcroft-Gault formula);
• •Patients with extrapulmonary TB only (without involvement of lung parenchyma)
• •Patients with documented ofloxacin resistance
• •Patients with XDR TB (additional resistance to SLD \[second line drug\] kanamycin (or capreomycin) AND ofloxacin);
• •Patients with resistance to both Km and Cm.
• •Critically ill and in the judgement of the treating physician unlikely to survive more than 1 week (these patients may still be commenced on standard MDR TB treatment according to the Karakalpakstan comprehensive TB treatment guidelines)
• •Has one or more of the following risk factors for QTc prolongation:
• •A confirmed prolongation of QTc interval (Fridericia formula), e.g., repeated demonstration of QTcF (Fridericia correction) interval \> 500 ms in the screening ECG (i.e., retesting to reassess eligibility will be allowed once using an unscheduled visit during the screening phase)