Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

Prior treatment

• Unable to take oral medications.
• Previously enrolled in similar studies.
• Received any investigational drug in the past 3 months.
• More than five (5) days of systemic treatment with any one or more of the following drugs within 30 days preceding initiation of study drugs: Isoniazid, rifampin, rifambutin, rifabentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin, capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline.

Other illness

• Patients with mental disorders and cognitive dysfunction.
• More than five (5) days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs.
• Known allergy or intolerance to any of the study medications.
• Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.
• Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.
  • Exclusions After Randomization:
• No M. tuberculosis is identified in the screening, baseline, and week 2 samples.
• Mycobacterium tuberculosis grown from or tested by molecular assays (Xpert MTB / RIF) in samples obtained before or after the study are determined to be resistant to isoniazid, rifampicin, or fluoroquinolones.

Lab values

• Known history of prolonged QT syndrome.

Other

• \- Exclusions Before Randomization:
• Pregnant or breast-feeding.
• With spinal tumors or metastatic tumors.
• Weight less than 40.0 kg.

• Age ≥ 12 years.
• Based on the medical history, clinical manifestations, radiological, laboratory tests and possible histological samples, the diagnostic criteria are met and judged to be mild spinal tuberculosis.
• Laboratory test values are completed within 14 days prior to screening.
• Women of child-bearing potential who are not surgically sterilized must agree to practice a barrier method of contraception or abstain from heterosexual intercourse during study drug treatment.
• For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening.
• Karnofsky score greater than or equal to 60.
• A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.
• Written informed consent.