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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT04187469
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or over, and an individual who completely bear the ability of civil actions.
* New cases of pulmonary tuberculosis. No previous anti-tuberculosis therapy or cumulatively taking anti-tuberculosis drugs for less than 1 month.
* Pulmonary tuberculosis patients with bacteriological diagnosis.
Exclusion Criteria:
* Suffering from tuberculous pleurisy.
* Patients with extrapulmonary tuberculosis.
* Renal insufficiency patients with creatinine clearance rate \<30 ml/min.
* Abnormal liver function (ALT and/or AST and/or TBIL greater than 2 times the upper limit of normal) or decompensated cirrhosis.
* HIV-Ab positive.
* Psychiatric patients, or have a previous history of mental illness, or recently have obvious anxiety or depression and other mental abnormalities.
* Patients receiving immunosuppressive therapy.
* Pregnant or breast feeding.
* Diabetes.
* X-pert MTB/RIF test of sputum or alveolar lavage fluid showed that Mycobacterium tuberculosis was rifampin resistant.
* Moxifloxacin was used within 14 days before entering the group.
* Anti-tuberculosis treatment has been started and drugs are being taken before entering the group.
* QT interval extension \> 480 ms.
* Combined with serious cardiovascular, liver, kidney, nervous system, blood system and other diseases or tumor diseases.
* Pulmonary lesions are widespread with respiratory insufficiency.
* Any other circumstances in which the anti-tuberculosis scheme of the experimental group or the control group cannot be selected for treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04187469
Study Brief:
Protocol Section:
NCT04187469