Shortened treatment options for people with asymptomatic pulmonary TB

Clinical Efficacy of a Short-course Regimen for Asymptomatic Tuberculosis in China

This project tests whether people with bacteriologically confirmed but symptom-free pulmonary tuberculosis can be treated safely with a 17-week standard-drug course or a 13-week high-dose rifapentine plus moxifloxacin course instead of the longer standard regimen.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 426 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 5 sites (Beijing, Beijing Municipality and 4 other locations)
• Trial ID: NCT06153069 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, multicenter, randomized controlled trial that enrolls people with bacteriologically confirmed pulmonary tuberculosis who have had no TB symptoms in the prior three months. Participants are randomized 1:1:1 to a standard 26-week regimen, a 17-week regimen using the same standard drugs but shortened, or a 13-week regimen using high-dose rifapentine with moxifloxacin. Randomization uses centralized stratified block methods across participating provinces to reduce bias. Treatment response is checked at end of therapy and continuation treatment may be extended by 8 weeks if sputum culture remains positive at week 8 or cavities have not closed on imaging.

Who should consider this trial

Good fit: Ideal candidates are people aged 14–80 with pulmonary specimens positive for M. tuberculosis (smear, culture, or molecular test), who have had no unexplained TB symptoms in the prior three months and who meet other local consent and contraception rules.

Not a fit: People with extrapulmonary TB, extensive lung lesions (involvement >50% or total cavity diameter >6 cm), known resistance in the M. tuberculosis isolate, or symptomatic TB at screening are not likely to benefit from these shortened regimens.

Why it matters

Potential benefit: If successful, the shorter regimens could safely reduce treatment time, side effects, and the burden of long therapy for people with asymptomatic TB.

How similar studies have performed: Previous trials of shorter rifapentine- or moxifloxacin-containing regimens have shown mixed results, with some promising signals but not yet a universal replacement of the standard long course.

Eligibility criteria

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\. 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 this trial is running

Beijing, Beijing Municipality and 4 other locations

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

Study contacts

• Principal investigator: Wenhong Zhang, Dr. — Huashan Hospital of Fudan University，Shanghai，China
• Study coordinator: Yang Li, Dr.

Conditions Tuberculosis; subclinical tuberculosis; shorter treatment