Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

Launched by SHANDONG UNIVERSITY · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying new treatment options for patients with mild spinal tuberculosis, a serious infection of the spine. The researchers want to see if a shorter treatment plan using different medications—rifapentine and moxifloxacin—can work just as well as the longer, traditional treatment. The goal is to find out if patients can safely complete their treatment in just 26 weeks instead of the usual longer timeframe.

To be eligible for this trial, participants should be at least 12 years old and diagnosed with mild spinal tuberculosis based on their medical history and tests. Women who can become pregnant must agree to use contraception during the study. Participants will receive close monitoring and support throughout the treatment period. It's important to know that people with certain health conditions, such as severe mental disorders or specific allergies to the study medications, will not be allowed to join the trial. If you think this study might be right for you or a loved one, it’s a good idea to speak with a healthcare professional for more information.

Gender

ALL

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.