Table 2 ORIENT inclusion and exclusion criteria

Inclusion criteria

1) Willing and able to participate in this trial, and signed informed consent (sign by the legal representative if patient has no civil capacity)

2) Aged of 18–60 years old

3) Weighed of 40–80 kg

4) Respiratory specimen positive for acid-fast bacilli on smear microscopy or positive for M. tuberculosis by Xpert® MTB/RIF (Cepheid, Sunnyvale, CA, USA)

5) Sensitive to rifampicin by molecular or phenotypic susceptibility testing

6) Has not received any anti-TB treatment in the past 6 months

7) If female patient not pregnant, willing to apply effective contraception during treatment

Exclusion criteria

1) Combined extrapulmonary tuberculosis

2) Extensive lesion (extent of disease greater than 50% or the aggregate diameter of all cavities greater than 6 cm)

3) M. tuberculosis isolate is already known to be resistant to at least one of the following: isoniazid, pyrazinamide, ethambutol, or fluoroquinolones

4) Patients with impaired liver function (Alanine aminotransferase or alkaline phosphatase or total bilirubin is higher than 1.5 times the upper limit of normal; hepatic encephalopathy, ascites)

5) White blood cell is less than normal or hemoglobin is less than 90 g/L or platelet is less than 100*10^9/L

6) Estimated glomerular filtration rate is less than 90 mL/min/1.73m²

7) HIV antibody positive and AIDS patients

8) Allergy or intolerance to any study drugs

9) Unable to take oral medications

10) If the following drugs are currently or are planned to be used within 6 months of enrollment: quinidine, procaine, amiodarone, sotalol, propylamine, zilasidone or tephenadine

11) Known history of optic neuritis, alcohol abuse, prolonged QT syndrome or QTcF over 450 ms at baseline, epilepsy, mental illness, diabetes with fundus disease, gout, porphyria, myasthenia gravis

12) Pregnant or breastfeeding