Actively Recruiting
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
Eligibility Criteria
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
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
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
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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