Mild Spinal TuberculosisPhase 2NCT06917495
Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
A Phase 2 study testing Rifampin, Isoniazid and Rifapentine (RPT) in people with Mild Spinal Tuberculosis, run by Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Mild Spinal Tuberculosis
- What is being tested?
- Rifampin, Isoniazid and Rifapentine (RPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Rifapentine- And Moxifloxacin-Containing Short-Course Regimens for Mild Spinal Tuberculosis: A Multicenter, Randomized, Non-inferiority Clinical Trial
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
- Being tested
- Rifampin, Isoniazid, Rifapentine (RPT), Moxifloxacin, Pyrazinamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampinDrug
Rifampin: once daily, 600 mg.
IsoniazidDrug
Isoniazid: once daily, 300 mg.
Rifapentine (RPT)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.
MoxifloxacinDrug
Moxifloxacin: once daily, 400 mg.
PyrazinamideDrug
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.
EthambutolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Empirical long course regimen | Active comparator | 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. Receives: Drug: Rifampin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol |
| Short-course regimen | Experimental | 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. Receives: Drug: Isoniazid; Drug: Rifapentine (RPT); Drug: Moxifloxacin; Drug: Pyrazinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB-recurrence rate of spinal tuberculosis at 24 months after completion of treatment.
The recurrence of spinal tuberculosis is defined by the reappearance of pain, with or without sinus formation, loosening or displacement of internal fixation on X-ray, and confirmed by postoperative CT or MRI showing increased local abscess, bone graft absorption, new sequestrum formation, or aggravated bone destruction.
Measured: 24 months after completion of treatment
The proportion of participants with grade 3 or more adverse events during study medication
Measured: Throughout the study drug treatment period, about 36 months
Secondary outcomes (8)
Clinical cure at the end of therapy
Clinical Healing: Spinal symptoms improved; pre-disease function restored; weight gain; no instability/neuro deficits.
Radiological Healing: Reduced epidural/paraspinal abscess/granulation; marrow reconversion; fatty bone reconstitution.
Measured: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
TB-recurrence rate of spinal tuberculosis 12 months after completion of treatment
Measured: 12 months after completion of treatment
The proportion of participants who are culture negative at eight weeks
Measured: At the end of 8 weeks of treatment
The proportion of discontinuation of assigned treatment for a reason other than microbiological ineligibility
Measured: Throughout the study period, an average of 1 year, up until the point of treatment discontinuation due to reasons other than microbiological failure
The incidence of adverse events
Measured: Throughout the study drug treatment period, about 36 months
The proportion of participants who have residual neurological dysfunction
Measured: Throughout the study drug treatment period, about 36 months
PK parameters of the anti-TB drugs
Maximum Plasma Concentration [Cmax], etc
Measured: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
PD target attainment rate of the anti-TB drugs
Cmax/MIC, etc
Measured: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start5 Apr 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Spinal TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Public Health Clinical Center
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Ph.D, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917495
- Sponsor's protocol ID
- SDU-2024-RPT-003
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu YE, Cao J, Wang L, Wei YJ, Liu HX, Qi L, Zhang W, Liu F, Zhu ZJ, Fan XT, Wang S, Chen C, Liu XZ, Li Y, Sun ZZ, Pan JB, Yang CQ, Van Den Anker J, Zhang Q, Zhao W. Rifapentine- and moxifloxacin-containing short-course regimens for mild spinal tuberculosis: study protocol for a multicenter, randomized, non-inferiority phase II clinical trial. Front Pharmacol. 2025 Dec 19;16:1684771. doi: 10.3389/fphar.2025.1684771. eCollection 2025.
PubMed 41487489
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifapentine- And Moxifloxacin-Containing Short-Course Regimens for Mild Spinal Tuberculosis: A Multicenter, Randomized, Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06917495
- Acronym / sponsor ID
- SDU-2024-RPT-003
- Conditions
- Mild Spinal Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Public Health Clinical Center
- Study start
- 5 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empirical long course regimen | Active comparator | Drug: Rifampin, Drug: Isoniazid, Drug: Pyrazinamide, Drug: EthambutolDrug: 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. |
| Short-course regimen | Experimental | Drug: Isoniazid, Drug: Rifapentine (RPT), Drug: Moxifloxacin, Drug: PyrazinamideDrug: 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- Exclusions Before Randomization:
- Pregnant or breast-feeding.
- Unable to take oral medications.
- Previously enrolled in similar studies.
- With spinal tumors or metastatic tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifampinRifampin: once daily, 600 mg. | Drug | Empirical long course regimen |
| IsoniazidIsoniazid: once daily, 300 mg. | Drug | Empirical long course regimen, Short-course regimen |
| 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. | Drug | Short-course regimen |
| MoxifloxacinMoxifloxacin: once daily, 400 mg. | Drug | Short-course regimen |
| PyrazinamidePyrazinamide: 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. | Drug | Empirical long course regimen, Short-course regimen |
| EthambutolEthambutol: 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. | Drug | Empirical long course regimen |
Primary outcome
TB-recurrence rate of spinal tuberculosis at 24 months after completion of treatment.
Time frame: 24 months after completion of treatment
The recurrence of spinal tuberculosis is defined by the reappearance of pain, with or without sinus formation, loosening or displacement of internal fixation on X-ray, and confirmed by postoperative CT or MRI showing increased local abscess, bone graft absorption, new sequestrum formation, or aggravated bone destruction.
The proportion of participants with grade 3 or more adverse events during study medication
Time frame: Throughout the study drug treatment period, about 36 months
8 secondary outcomes
Clinical cure at the end of therapy
Time frame: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
TB-recurrence rate of spinal tuberculosis 12 months after completion of treatment
Time frame: 12 months after completion of treatment
The proportion of participants who are culture negative at eight weeks
Time frame: At the end of 8 weeks of treatment
The proportion of discontinuation of assigned treatment for a reason other than microbiological ineligibility
Time frame: Throughout the study period, an average of 1 year, up until the point of treatment discontinuation due to reasons other than microbiological failure
The incidence of adverse events
Time frame: Throughout the study drug treatment period, about 36 months
The proportion of participants who have residual neurological dysfunction
Time frame: Throughout the study drug treatment period, about 36 months
PK parameters of the anti-TB drugs
Time frame: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
PD target attainment rate of the anti-TB drugs
Time frame: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 41487489Wu YE, Cao J, Wang L, Wei YJ, Liu HX, Qi L, Zhang W, Liu F, Zhu ZJ, Fan XT, Wang S, Chen C, Liu XZ, Li Y, Sun ZZ, Pan JB, Yang CQ, Van Den Anker J, Zhang Q, Zhao W. Rifapentine- and moxifloxacin-containing short-course regimens for mild spinal tuberculosis: study protocol for a multicenter, randomized, non-inferiority phase II clinical trial. Front Pharmacol. 2025 Dec 19;16:1684771. doi: 10.3389/fphar.2025.1684771. eCollection 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Zhao, Ph.D principal investigator
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifampin, Isoniazid and Rifapentine (RPT) in people with Mild Spinal Tuberculosis, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB-recurrence rate of spinal tuberculosis at 24 months after completion of treatment. (time frame: 24 months after completion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.