Clinical Research Directory

Inclusion Criteria: A patient will be eligible for entry to the study if he/she: * Is willing and able to give informed consent to be enrolled in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate) * Is aged 18 years or older * Has bacteriologically-confirmed pulmonary tuberculosis by Xpert MTB/RIF, other nucleic acid amplification test, or culture * With initial laboratory result of resistance to rifampicin by Xpert MTB/RIF or Xpert MTB/RIF ultra, or other DST (line probe assay, culture); and with initial laboratory result that is susceptible to isoniazid by Xpert MTB/RIF or other DST. If rifampicin resistance is detected by Xpert MTB/RIF or Xpert MTB/RIF ultra in specimens with very low bacillary, rifampicin resistance has been confirmed by a repeat molecular test. * With initial laboratory result of being susceptible to rifampicin by Xpert MTB/RIF or other DST (Xpert MTB/RIF ultra, line probe assay, culture) but are not able to tolerate rifampicin for whom rifabutin is intolerable or clinically not indicated; and with initial laboratory result that is susceptible to isoniazid by Xpert MTB/RIF or other DST * With initial laboratory result of being susceptible to rifampicin by Xpert MTB/RIF or other DST (Xpert MTB/RIF ultra, line probe assay, culture) but rifamycin-sparing regimens are preferred due to drug-drug interaction, such as organ transplant recipients; and with initial laboratory result that is susceptible to isoniazid by Xpert MTB/RIF or other DST. * With initial laboratory result that is susceptible to fluoroquinolone by Xpert MTB/XDR or other DST. * If HIV test positive, is willing to be treated with ART in accordance with the national policies. * Agrees to use effective barrier contraception or have an intrauterine contraceptive device during treatment phase if a pre-menopausal woman * Has an identifiable address and expects to remain in the area for the duration of the study * Is willing to adhere to the follow-up schedule and to study procedures Exclusion Criteria: A patient will not be eligible for entry to the study if he/she: * Is infected with a strain of M. Tuberculosis resistant to isoniazid by Xpert MTB/XDR or other tests * Is infected with a strain of M. Tuberculosis resistant to fluoroquinolone by Xpert MTB/XDR or other tests * Is infected with a strain of M. Tuberculosis resistant to amikacin by Xpert MTB/XDR or other tests and have no result of susceptibility of isoniazid by conventional drug susceptibility testing * Has tuberculous meningitis or bone and joint tuberculosis * Is critically ill, and in the judgment of the investigator, unlikely to survive more than 4 months. * Is known to be pregnant or breast-feeding * Is unable to attend or comply with treatment or follow-up schedule * Is unable to take oral medication * Has AST or ALT \>5 times the upper limit of normal * Has AST or ALT \> 3 times the upper limit of normal ,and either with symptoms of hepatitis or bilirubin \> 1.5 times the upper limit of normal * Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe. * Is taking any medications contraindicated with the medicines in either the trial or control regimen * Has a known allergy to any fluoroquinolone antibiotic * Is currently taking part in another trial of a medicinal product * Has a QTcF interval of ≥450msec at screening