Shortened treatment options for people with asymptomatic pulmonary TB

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• The First People's Hospital of Linping District, Hangzhou
  Hangzhou, Zhejiang, China Recruiting
• Huashan Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Active not recruiting

Study contacts

• Principal investigator: Wenhong Zhang, Dr. — Huashan Hospital of Fudan University，Shanghai，China
• Study coordinator: Yang Li, Dr.
• Email: y_li11@fudan.edu.cn
• Phone: (086)18817583793

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.