Asymptomatic TB With Innovative Modified Short-course Regimens
China426 participantsStarted 2025-11-21
Plain-language 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.
Who can participate
Age range14 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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\. Pregn…