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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT02623556
Eligibility Criteria:
Inclusion Criteria of TB (tuberculosis:include pulmonary tuberculosis and extra pulmonary tuberculosis) subjects:
* judge the pulmonary tuberculosis patient according to Health industry standard of the People's Republic of China WS288-2008:Diagnostic Criteria for pulmonary tuberculosis;
* 18 to 65 years old ,no gender limited;
* Consent and signed informed consent forms (ICF);
* Comply with follow-up.
Inclusion Criteria of extra pulmonary tuberculosis subjects:
* Diagnosed extra pulmonary tuberculosis by epidemiology, imaging, clinical symptoms, pathological examination and so on;
* Lesions outside the lungs;
* be in unfinished reinforced phase by chemotherapy;
Exclusion Criteria of TB (tuberculosis) subjects:
* Accompanied by the following severe illness:advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
* Taking part in other clinical or within three months involved in any other clinical;
* Severe allergic constitution:allergic to two or more drugs;
* in pregnancy or lactation;
* in a mental illness;
* Any conditions affect the trial evaluation by investigator's judgement.
Inclusion Criteria of non-TB participants with lung disease:
* A clear lung disease but can exclude pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination.
* 18 to 65 years old, no gender limited;
* Consent and signed informed consent forms (ICF);
* Comply with follow-up.
Exclusion Criteria of non-TB participants with lung disease:
* Accompanied by the following severe illness: advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
* Taking part in other clinical or within three months involved in any other clinical;
* Severe allergic constitution: allergic to two or more drugs;
* in pregnancy or lactation;
* in a mental illness;
* history of tuberculosis;
* Any conditions affect the trial evaluation by investigator's judgement.
Inclusion Criteria of suspected TB participants with lung disease:
* Cases who have pulmonary tuberculosis by clinical symptoms/signs:appear cough、cough with hemoptysis、pectoralgia、dyspnea、fever（low-grade fever at afternoon）,together with night sweats、weak、loss of appetite、weight loss,and so on,or other easily-confused respiratory system disease with TB;
* 18 to 65 years old, no gender limited;
* Consent and signed informed consent forms (ICF);
* Comply with follow-up.
Exclusion Criteria of suspected TB participants with lung disease:
* Accompanied by the following severe illness: advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
* Taking part in other clinical or within three months involved in any other clinical;
* Severe allergic constitution: allergic to two or more drugs;
* in pregnancy or lactation;
* in a mental illness;
* history of tuberculosis;
* Any conditions affect the trial evaluation by investigator's judgement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02623556
Study Brief:
Protocol Section:
NCT02623556