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Asymptomatic TB With Innovative Modified Short-course Regimens

NCT06153069 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2026-02-11

No results posted yet for this study

Summary

This study is a randomized controlled trial among asymptomatic tuberculosis individuals aiming to assess whether the standard treatment duration can be shortened to 17 weeks without increasing the types or doses of anti-tuberculosis medications or 13 weeks with the high-dose rifapentine and moxifloxacin.

Conditions

Interventions

DRUG

Four-month regimen

The four-month regimen consists of a 17-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 9 weeks with HR. If the sputum culture remains positive at week 8, or if the radiological examination at the end of treatment still shows unclosed cavities, the continuation phase treatment will be extended by an additional 8 weeks.

DRUG

Three-month regimen

Three-month regimen consists of two periods of 13-21 weeks. During the intensive phase (8 weeks), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; pyrazinamide \<50.0kg 1000mg daily, 50.0-70.9kg 1500 mg daily, ≥71kg 2000mg daily. During the continuation phase (5 or 13 weeks based on the culture resultes and radiological manifestations), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; All treatment is taken orally. For rifapentine administration, the daily dosage may be reduced to 600mg if intolerance occurs.

DRUG

Standard regimen

The standardized regimen consists of a 26-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 18 weeks with HR.

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Wenhong Zhang, Dr. · Huashan Hospital of Fudan University，Shanghai，China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-21
Primary Completion
2027-11-30
Completion
2028-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06153069 on ClinicalTrials.gov