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Asymptomatic TB With Innovative Modified Short-course Regimens

RecruitingPhase 4Ages 14 Years - 80 YearsAllHuashan Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Four-month regimen
  • Three-month regimen
  • Standard regimen
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Where

5 sites
Beijing Chest Hospital, Capital Medical University
Beijing, China
Liupanshui City Third People's Hospital
Liupanshui, China
Nayong County People's Hospital
Nayong, China
Huashan Hospital of Fudan University
Shanghai, China
The First People's Hospital of Linping District, Hangzhou
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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