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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Shandong Public Health Clinical Center
Jinan, China
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
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
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
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
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Moxifloxacin: once daily, 400 mg.
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: 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.
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
Maximum Plasma Concentration \[Cmax\], etc
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
Cmax/MIC, etc
Time frame: At the end of therapy, WEEK 52 for empirical long-course regimen, WEEK 26 for Short-course regimen