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
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
Treatments tested in this trial
- Rifampin
- Isoniazid
- Rifapentine (RPT)
- Moxifloxacin
- Pyrazinamide
- Ethambutol
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shandong University
Lead sponsor
Shandong Public Health Clinical Center
Collaborator
Source ClinicalTrials.gov