Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

NCT ID: NCT06917495

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-05
• Study Completion Date: 2029-12-31

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, while isoniazid and pyrazinamide remaining the same as the empirical regimen) and the empirical long-course regimen, so as to determine whether it is possible to shorten the treatment duration to 26 weeks for patients with mild spinal tuberculosis.

Conditions

Mild Spinal Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empirical long course regimen

Drug: Rifampicin, once daily, 600 mg, administered for 52 weeks. Drug: Isoniazid, once daily, 300 mg, administered for 52 weeks. Drug: Pyrazinamide, once daily, dosage adjusted based on body weight: 1000 mg for < 55 kg, 1500 mg for ≥ 55-75 kg, and 2000 mg for > 75 kg, administered for the first 8 weeks.

Drug: Ethambutol, once daily, dosage adjusted based on body weight: 800 mg for < 55 kg, 1200 mg for ≥ 55-75 kg, and 1600 mg for > 75 kg, administered for the first 8 weeks.

Group Type: ACTIVE_COMPARATOR

Rifampin

Intervention Type: DRUG

Rifampin: once daily, 600 mg.

Isoniazid

Intervention Type: DRUG

Isoniazid: once daily, 300 mg.

Pyrazinamide

Intervention Type: DRUG

Pyrazinamide: once daily with dosage adjusted based on body weight: 1000 mg for \< 55 kg, 1500 mg for ≥ 55-75 kg, and 2000 mg for \>75 kg.

Ethambutol

Intervention Type: DRUG

Ethambutol: once daily with dosage adjusted based on body weight: 800 mg for \< 55 kg, 1200 mg for ≥ 55-75 kg, and 1600 mg for \> 75 kg.

Short-course regimen

Drug: Rifapentine, once daily, dosage adjusted based on body weight: 750 mg for ≤41.2 kg, 900 mg for >41.3-48.7 kg, 1050 mg for > 48.8-56.2 kg, 1200 mg for ≥ 56.3 kg, administered for 26 weeks.

Drug: Moxifloxacin, once daily, 400 mg, administered for 26 weeks. Drug: Isoniazid, once daily, 300 mg, administered for 26 weeks. Drug: Pyrazinamide, once daily, dosage adjusted based on body weight: 1000 mg for < 55 kg, 1500 mg for ≥ 55-75 kg, and 2000 mg for >75 kg, administered for the first 8 weeks.

Group Type: EXPERIMENTAL

Isoniazid

Intervention Type: DRUG

Isoniazid: once daily, 300 mg.

Rifapentine (RPT)

Intervention Type: DRUG

Rifapentine: once daily with dosage adjusted based on body weight: 750 mg for ≤41.2 kg, 900 mg for \>41.3-48.7 kg, 1050 mg for \> 48.8-56.2 kg, 1200 mg for ≥ 56.3 kg.

Moxifloxacin

Intervention Type: DRUG

Moxifloxacin: once daily, 400 mg.

Pyrazinamide

Intervention Type: DRUG

Pyrazinamide: once daily with dosage adjusted based on body weight: 1000 mg for \< 55 kg, 1500 mg for ≥ 55-75 kg, and 2000 mg for \>75 kg.

Interventions

Rifampin

Rifampin: once daily, 600 mg.

Intervention Type: DRUG

Isoniazid

Isoniazid: once daily, 300 mg.

Intervention Type: DRUG

Rifapentine (RPT)

Rifapentine: once daily with dosage adjusted based on body weight: 750 mg for ≤41.2 kg, 900 mg for \>41.3-48.7 kg, 1050 mg for \> 48.8-56.2 kg, 1200 mg for ≥ 56.3 kg.

Intervention Type: DRUG

Moxifloxacin

Moxifloxacin: once daily, 400 mg.

Intervention Type: DRUG

Pyrazinamide

Pyrazinamide: once daily with dosage adjusted based on body weight: 1000 mg for \< 55 kg, 1500 mg for ≥ 55-75 kg, and 2000 mg for \>75 kg.

Intervention Type: DRUG

Ethambutol

Ethambutol: once daily with dosage adjusted based on body weight: 800 mg for \< 55 kg, 1200 mg for ≥ 55-75 kg, and 1600 mg for \> 75 kg.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Public Health Clinical Center

OTHER_GOV

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Zhao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Locations

Shandong Public Health Clinical Center

Jinan, , China

Countries

China

Central Contacts

Wei Zhao, Ph.D

Role: CONTACT

zhao4wei2@hotmail.com

86053188383308

Facility Contacts

Qiang Zhang

Role: primary

Other Identifiers

SDU-2024-RPT-003

Identifier Type: -

Identifier Source: org_study_id