Asymptomatic TB With Innovative Modified Short-course Regimens

Recruiting now · Phase 4

Conditions studied: Tuberculosis

In brief

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.

Key facts

Study ID

NCT06153069

Run by

Huashan Hospital

People needed

426

Starts

2025-11-21

Expected to finish

2028-11-01

Last updated by the study team

2026-02-11

Who can join

Age: 14 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 1. Combined extrapulmonary tuberculosis;
• 2. Induviduals with extensive lesion (lesion involvement exceeding 50% or the aggregate diameter of all cavities exceeding 6 cm) ;
• 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;
• 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;
• 7. Known allergic or intolerant to any of the study drugs;
• 8. Pregnant or breast-feeding;
• 9. Prior anti-TB treatment for more than one week in the past six months;
• 10.Known history of epilepsy, uncontrolled diabetes;
• 11.For HIV-positive subjects, T-lymphocyte (CD4 cell) counts less than 100 cells/mm3;
• 12. Unable to tolerant oral treatment.

Where it is running

• Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Liupanshui City Third People's Hospital — Liupanshui, Guizhou, China (enrolling)
• Nayong County People's Hospital — Nayong, Guizhou, China (enrolling)
• The First People's Hospital of Linping District, Hangzhou — Hangzhou, Zhejiang, China (enrolling)
• Huashan Hospital of Fudan University — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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