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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT02619994
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged from 19 to 85 years
* Confirmed MDR-TB or RR-TB
* On current TB therapy for ≤14 days at the time of enrollment.
Exclusion Criteria:
* Known any quinolone-resistant MDR-TB
* Known XDR-TB
* who are pregnant or who are unwilling to use proper contraceptives at childbearing age
* Medical history of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* The need for ongoing use of prohibited drugs while on study drugs
* History of optic neuropathy or peripheral neuropathy
* With any of the following test results: i.Absolute neutrophil count \< 2000 cells/mL, ii.White blood cell count (WBC) \< 3.0 X 103/µL, iii.Hemoglobin \< 7.0 g/dL, iv.Serum creatinine \> 2.0 mg/dL, v.Aspartate aminotransferase (AST or SGOT) \>100 IU/L, vi.Alanine aminotransferase (ALT or SGPT) \>100 IU/L, vii.Total bilirubin \> 2.0 mg/dL, viii.Albumin \< 2.8g/dL, ix.QTcF \> 500ms
* History of hypersensitivity reaction to the study drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT02619994
Study Brief:
Protocol Section:
NCT02619994