RECRUITINGPhase 4INTERVENTIONAL

Asymptomatic TB With Innovative Modified Short-course Regimens

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 1\. Age between 14 to 80 years; - 2\. Male or female; - 3\. Willing to provide signed willing to sign a consent form, 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Four-month regimen

The four-month regimen consists of a 17-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 9 weeks with HR. 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.

DRUG

Three-month regimen

Three-month regimen consists of two periods of 13-21 weeks. During the intensive phase (8 weeks), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; pyrazinamide \<50.0kg 1000mg daily, 50.0-70.9kg 1500 mg daily, ≥71kg 2000mg daily. During the continuation phase (5 or 13 weeks based on the culture resultes and radiological manifestations), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; All treatment is taken orally. For rifapentine administration, the daily dosage may be reduced to 600mg if intolerance occurs.

DRUG

Standard regimen

The standardized regimen consists of a 26-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 18 weeks with HR.

Locations (5)

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Liupanshui City Third People's Hospital

Liupanshui, Guizhou, China

Nayong County People's Hospital

Nayong, Guizhou, China

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

The First People's Hospital of Linping District, Hangzhou

Hangzhou, Zhejiang, China