Asymptomatic TB With Innovative Modified Short-course Regimens

Last updated: February 8, 2026
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Lung Disease

Hiv

Treatment

Short-course regimen

Four-month regimen

Three-month regimen

Clinical Study ID

NCT06153069
KY2023-715
  • Ages 14-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Age between 14 to 80 years;
    1. Male or female;
    1. Willing to provide signed informed consent, or parental consent and participantassent;
    1. Individuals with respiratory tract specimen (including sputum/bronchoalveolarlavage fluid/lung tissue) positive for acid-fast bacilli smear/culture/molecularamplification for M. tuberculosis;
    1. 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;
    1. If non-menopausal woman, agree to use or have used effective contraception duringtreatment.

Exclusion

Exclusion Criteria:

    1. Combined extrapulmonary tuberculosis;
    1. Induviduals with extensive lesion (lesion involvement exceeding 50% or theaggregate diameter of all cavities exceeding 6 cm) ;
    1. Individuals will be excluded from enrollment if, at the time of enrollment, theirM. tuberculosis isolate is already known to be resistant to any one or more of thefollowing: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones;
    1. Individuals with impaired liver function (alanine transaminase [ALT] or totalbilirubin [TBIL] more than 2.5 times the upper limit of normal) or combined withliver cirrhosis;
    1. Hemoglobin is less than 70g/L, or platelet is less than 50*10^9/L;
    1. Estimated Glomerular Filtration Rate (eGFR) is less than 30 mL/min/1.73m2;
    1. Known allergic or intolerant to any of the study drugs;
    1. Pregnant or breast-feeding;
    1. 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 100cells/mm3;

    1. Unable to tolerant oral treatment.

Study Design

Total Participants: 426
Treatment Group(s): 4
Primary Treatment: Short-course regimen
Phase: 4
Study Start date:
November 21, 2025
Estimated Completion Date:
November 30, 2028

Study Description

This study is a prospective, open-label, multicenter randomized controlled trial. The randomization process will use centralized stratified block randomization to minimize bias across province of participating sites.

Asymptomatic tuberculosis individuals included in the study will be randomly assigned in a 1:1:1 ratio to three groups: Standard Regimen Group, Four-month Regimen Group or Three-month Regimen Group. The standard regimen consists of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E) for 8 weeks, followed by rifampicin and isoniazid for an additional 18 weeks. The four-month regimen group follows the same regimen as the standard regimen group for the initial 8 weeks, followed by a continuation phase of daily rifampin (R) and isoniazid (H) for 9 weeks. The three-month regimen consists of high-dose rifapentine (P), isoniazid (H), pyrazinamide (Z), and moxifloxacin (M) for 8 weeks, followed high-dose Rifapentine (P), isoniazid (H), and moxifloxacin (M) for 5 weeks. For individuals in the four-month and the three-month regimen group, the treatment response will be evaluated at the end of the treatment phase. If the sputum culture remains positive at week 8, or if the radiological examination at the end of treatment still shows unclosed cavities, the continuation phase treatment will be extended by an additional 8 weeks.

Connect with a study center

  • Beijing Chest Hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 200040
    China

    Active - Recruiting

  • Liupanshui City Third People's Hospital

    Liupanshui 8533133, Guizhou 1809445
    China

    Active - Recruiting

  • Nayong County People's Hospital

    Nayong 1799501, Guizhou 1809445 200040
    China

    Active - Recruiting

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Huashan Hospital of Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Site Not Available

  • Hangzhou Red Cross Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The First People's Hospital of Linping District, Hangzhou

    Hangzhou 1808926, Zhejiang 1784764
    China

    Active - Recruiting

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