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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01994460
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged from 20 to 80 years (20- and 80-year-old patients can participate).
* Documented sputum Xpert MTB/RIF assay-positive pulmonary TB at screening.
* On current TB therapy (if any) for ≤14 days at the time of enrollment.
Exclusion Criteria:
* Patients with HIV/AIDS.
* Females of childbearing potential, who are pregnant, breastfeeding, or unwilling to avoid pregnancy.
* Any of the following:
i.Absolute neutrophil count of \<2000 cells/mL. ii.White blood cell count (WBC) of \<3000/μL. iii.Hemoglobin concentration of \<7.0 g/dL. iv.Serum creatinine level of \>2.0 mg/dL. v.Aspartate aminotransferase (AST or SGOT) of \>100 IU/L. vi.Alanine aminotransferase (ALT or SGPT) of \>100 IU/L. vii.Total bilirubin level of \>2.0 mg/dL. viii.History of optic neuritis or peripheral neuropathy. ix.Other significant laboratory abnormalities (i.e., absolute neutrophil count, creatinine level).
x.The need for ongoing therapy with SSRIs, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, buspirone, monoamine oxidase inhibitors (MAOIs), sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), or dopaminergic agents (e.g., dopamine, dobutamine).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT01994460
Study Brief:
Protocol Section:
NCT01994460