Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT06917495
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 12 years.
2. 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.
3. Laboratory test values are completed within 14 days prior to screening.
4. 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.
5. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening.
6. Karnofsky score greater than or equal to 60.
7. 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.
8. Written informed consent.
Exclusion Criteria:
\- Exclusions Before Randomization:
1. Pregnant or breast-feeding.
2. Unable to take oral medications.
3. Previously enrolled in similar studies.
4. With spinal tumors or metastatic tumors.
5. Patients with mental disorders and cognitive dysfunction.
6. Received any investigational drug in the past 3 months.
7. More than five (5) days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs.
8. 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.
9. Known history of prolonged QT syndrome.
10. Weight less than 40.0 kg.
11. Known allergy or intolerance to any of the study medications.
12. 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.
13. Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.
* Exclusions After Randomization:
14. No M. tuberculosis is identified in the screening, baseline, and week 2 samples.
15. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT06917495
Study Brief:
Protocol Section:
NCT06917495