Clinical trial NCT06917495: Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
Official title: Rifapentine- And Moxifloxacin-Containing Short-Course Regimens for Mild Spinal Tuberculosis: A Multicenter, Randomized, Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Mild Spinal Tuberculosis
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong Public Health Clinical Center
First posted: 2025-04-08
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: TB-recurrence rate of spinal tuberculosis at 24 months after completion of treatment.
timeFrame: 24 months after completion of treatment
measure: The proportion of participants with grade 3 or more adverse events during study medication
timeFrame: Throughout the study drug treatment period, about 36 months
Secondary outcomes:
measure: Clinical cure at the end of therapy
timeFrame: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
measure: TB-recurrence rate of spinal tuberculosis 12 months after completion of treatment
timeFrame: 12 months after completion of treatment
measure: The proportion of participants who are culture negative at eight weeks
timeFrame: At the end of 8 weeks of treatment
measure: The proportion of discontinuation of assigned treatment for a reason other than microbiological ineligibility
timeFrame: Throughout the study period, an average of 1 year, up until the point of treatment discontinuation due to reasons other than microbiological failure
measure: The incidence of adverse events
timeFrame: Throughout the study drug treatment period, about 36 months
measure: The proportion of participants who have residual neurological dysfunction
timeFrame: Throughout the study drug treatment period, about 36 months
measure: PK parameters of the anti-TB drugs
timeFrame: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
measure: PD target attainment rate of the anti-TB drugs
timeFrame: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: