Actively Recruiting

Phase 4
Age: 14Years - 80Years
All Genders
NCT06153069

Asymptomatic TB With Innovative Modified Short-course Regimens

Led by Huashan Hospital · Updated on 2026-02-11

426

Participants Needed

5

Research Sites

153 weeks

Total Duration

On this page

Sponsors

H

Huashan Hospital

Lead Sponsor

U

University of Toronto

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Asymptomatic TB With Innovative Modified Short-course Regimens

Who Can Participate

Age: 14Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 14 to 80 years
  • Male or female
  • Willing to provide signed informed consent, or parental consent and participant assent
  • Positive respiratory specimen for Mycobacterium tuberculosis by smear, culture, or molecular test
  • No tuberculosis symptoms such as cough longer than two weeks, night sweats, fever, or weight loss in the past three months
  • If a non-menopausal woman, agrees to use or has used effective contraception during treatment
Not Eligible

You will not qualify if you...

  • Presence of extrapulmonary tuberculosis
  • Extensive lung lesions covering more than 50% or total cavity size over 6 cm
  • Known resistance to rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones at enrollment
  • Impaired liver function with ALT or total bilirubin more than 2.5 times the normal limit or liver cirrhosis
  • Hemoglobin less than 70 g/L or platelet count less than 50 x 10^9/L
  • Estimated glomerular filtration rate below 30 mL/min/1.73m2
  • Known allergy or intolerance to any study drugs
  • Pregnant or breastfeeding
  • Previous anti-tuberculosis treatment for more than one week in the past six months
  • History of epilepsy or uncontrolled diabetes
  • For HIV-positive individuals, CD4 count less than 100 cells/mm3
  • Unable to tolerate oral treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 200040

Actively Recruiting

2

Liupanshui City Third People's Hospital

Liupanshui, Guizhou, China

Actively Recruiting

3

Nayong County People's Hospital

Nayong, Guizhou, China, 200040

Actively Recruiting

4

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200040

Active, Not Recruiting

5

The First People's Hospital of Linping District, Hangzhou

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

Y

Yang Li, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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