Testing shorter tuberculosis drug courses in people without symptoms
Tests shorter tuberculosis drug treatments in people with tuberculosis who have no symptoms.
Plain-language title generated from the registry record
Registry title: Asymptomatic TB With Innovative Modified Short-course Regimens
Key facts
- Where
- Beijing, Hangzhou, Liupanshui, Nayong, and Shanghai, ChinaSee the 5 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 80 years old?
Source: NCT06153069, who can take part
Where in China
- Beijing chest hospital, Capital Medical UniversityBeijing, ChinaTaking people
- The First People's Hospital of Linping District, HangzhouHangzhou, ChinaTaking people
- Liupanshui City Third People's HospitalLiupanshui, ChinaTaking people
- Nayong County People's HospitalNayong, ChinaTaking people
- Huashan Hospital of Fudan UniversityShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT06153069
- Record updated
- 11 February 2026
- Original description
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.Read full original descriptionShow less
Clinical Efficacy of a Short-course Regimen for Asymptomatic Tuberculosis in China
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.
Inclusion: 1. Age between 14 to 80 years; 2. Male or female; 3. Willing to provide signed informed consent, or parental consent and participant assent; 4. Individuals with respiratory tract specimen (including sputum/bronchoalveolar lavage fluid/lung tissue) positive for acid-fast bacilli smear/culture/molecular amplification for M. tuberculosis; 5. No unexplained TB-suggestive symptoms in the three months prior to screening, including cough lasting more than two weeks, night sweats, fever or weight loss; 6. If non-menopausal woman, agree to use or have used effective contraception during treatment.
Exclusion: 9. Prior anti-TB treatment for more than one week in the past six months; 1. Combined extrapulmonary tuberculosis; 3. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones; 7. Known allergic or intolerant to any of the study drugs; 10.Known history of epilepsy, uncontrolled diabetes; 4. Individuals with impaired liver function (alanine transaminase [ALT] or total bilirubin [TBIL] more than 2.5 times the upper limit of normal) or combined with liver cirrhosis; 5. Hemoglobin is less than 70g/L, or platelet is less than 50*10\^9/L; 6. Estimated Glomerular Filtration Rate (eGFR) is less than 30 mL/min/1.73m2; 11.For HIV-positive subjects, T-lymphocyte (CD4 cell) counts less than 100 cells/mm3; 2. Induviduals with extensive lesion (lesion involvement exceeding 50% or the aggregate diameter of all cavities exceeding 6 cm) ; 8. Pregnant or breast-feeding; 12. Unable to tolerant oral treatment.