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Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

NCT06917495 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

  • Mild Spinal Tuberculosis

Interventions

DRUG

Rifampin

Rifampin: once daily, 600 mg.

DRUG

Isoniazid

Isoniazid: once daily, 300 mg.

DRUG

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

Moxifloxacin

Moxifloxacin: once daily, 400 mg.

DRUG

Pyrazinamide

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.

DRUG

Ethambutol

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.

Sponsors & Collaborators

  • Shandong Public Health Clinical Center

    collaborator OTHER_GOV

  • Shandong University

    lead OTHER

Principal Investigators

  • Wei Zhao, Ph.D · Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-05
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917495 on ClinicalTrials.gov