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Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

ConditionMild Spinal Tuberculosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorShandong University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant or breast-feeding.

Unable to take oral medications.

Previously enrolled in similar studies.

With spinal tumors or metastatic tumors.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rifampin

    Drug

    Rifampin: once daily, 600 mg.

  • Isoniazid

    Drug

    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.

  • Moxifloxacin

    Drug

    Moxifloxacin: once daily, 400 mg.

  • Pyrazinamide

    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

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Empirical long course regimenActive comparator 4 interventions
Group B: Short-course regimenExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
24 months after completion of treatment
2

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

Secondary outcomes

1

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.

Time frame
At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen
2

TB-recurrence rate of spinal tuberculosis 12 months after completion of treatment

Time frame
12 months after completion of treatment
3

The proportion of participants who are culture negative at eight weeks

Time frame
At the end of 8 weeks of treatment
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong University

Lead sponsor

Shandong Public Health Clinical Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: