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NCT06153069RecruitingPhase 4

Asymptomatic TB With Innovative Modified Short-course Regimens

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

Source: ClinicalTrials.gov · Last updated 11 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
426 (estimated)
First submitted
22 Nov 2023
Start date
21 Nov 2025
Primary completion date
Nov 2027
Lead sponsor
Huashan Hospital
Diseases
Tuberculosis
NCT number
NCT06153069

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 426
  • From 21 Nov 2025 to the primary completion date, Nov 2027
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 9\. Prior anti-TB treatment for more than one week in the past six months;

Other illness

  • 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;

Lab values

  • 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;

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 14 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing chest hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
The First People's Hospital of Linping District, Hangzhou
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Liupanshui City Third People's Hospital
Coordinator of this site? Confirm its status
LiupanshuiChinaRecruiting
Nayong County People's Hospital
Coordinator of this site? Confirm its status
NayongChinaRecruiting
Huashan Hospital of Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.