Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT06153069
Eligibility Criteria:
Inclusion Criteria:
* 1\. Age between 14 to 80 years;
* 2\. Male or female;
* 3\. Weight between 40 to 80 kg;
* 4\. Willing to provide signed informed consent, or parental consent and participant assent.
* 5\. Individuals with respiratory tract specimen (including sputum/induced sputum/bronchoalveolar lavage fluid/lung tissue) smear/culture/rapid molecular tests-positive pulmonary tuberculosis;
* 6\. No tuberculosis related symptoms that could not be explained by other causes within 6 months before enrollment. Tuberculosis related symptoms includes cough for more than 2 weeks, expectoration, hemoptysis, fever, night sweats, and weight loss.
* 7\. Not received any anti-TB treatment in the past 6 months
* 8\. If non-menopausal woman, agree to use or have used effective contraception during treatment.
Exclusion Criteria:
* 1\. Combined extrapulmonary tuberculosis;
* 2\. Patients with extensive lesion (extent of disease greater than 50% or cavity size greater than 4cm) ;
* 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\. Patients with impaired liver function (alanine transaminase \[ALT\], alkaline phosphatase \[ALP\] or total bilirubin \[TBIL\] more than 2 times the upper limit of normal) or combined with liver cirrhosis;
* 5\. Leucocyte is less than 3×10\^9/L, or hemoglobin is less than 90g/L, or platelet is less than 100\*10\^9/L;
* 6\. Estimated Glomerular Filtration Rate (eGFR) is less than 60 mL/min/1.73m2
* 7\. Known allergic or intolerant to any of the study drugs
* 8\. Can not take oral medications
* 9\. HIV antibody positive and AIDS patients
* 10.Have optic neuritis, alcoholism, epilepsy, mental illness, diabetes mellitus with fundus lesions, porphyria, myasthenia gravis
* 11.Pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
80 Years
Study:
NCT06153069
Study Brief:
Protocol Section:
NCT06153069