Status:
NOT_YET_RECRUITING
Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
Lead Sponsor:
Shandong University
Collaborating Sponsors:
Shandong Public Health Clinical Center
Conditions:
Mild Spinal Tuberculosis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
To evaluate the non-inferiority in efficacy between the rifapentine- and moxifloxacin-containing short-course regimens (with rifampicin replaced by rifapentine and ethambutol replaced by moxifloxacin,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- \- Exclusions Before Randomization:
- Pregnant or breast-feeding.
- Unable to take oral medications.
- Previously enrolled in similar studies.
- With spinal tumors or metastatic tumors.
- Patients with mental disorders and cognitive dysfunction.
- Received any investigational drug in the past 3 months.
- More than five (5) days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs.
- 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.
- Known history of prolonged QT syndrome.
- Weight less than 40.0 kg.
- 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.
Key Trial Info
Start Date :
April 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06917495
Start Date
April 5 2025
End Date
December 31 2029
Last Update
April 8 2025
Active Locations (1)
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1
Shandong Public Health Clinical Center
Jinan, China