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 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT07209761
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥14 years
2. Body weight ≥30.0 kg
3. Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
4. Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
5. Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
6. Chest radiograph consistent with active TB disease
7. Able to provide sputum sample
8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
9. Willing to have HIV test (unless previous positive result confirmed)
10. For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load \<200 copies/mL, and CD4 count \>100 cells/mL
Exclusion Criteria:
1. Known/suspected resistance to BDQ, PMD, LZD, or QBS
2. Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
3. Severe extrapulmonary TB
4. Abnormal laboratory values: ALT/AST \>2.5×ULN, Total bilirubin \>1.5×ULN, eGFR \<60 mL/min/1.73m², Hemoglobin \<8 g/dL, Platelets \<100,000 cells/mm³, WBC \<2.0×10⁹/L, ANC \<1000 cells/μL, and HbA1c \>9.0%
5. Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment
6. Co-enrollment in other therapeutic trials
7. QTcF \>450 msec (males) or \>470 msec (females)
8. Clinically significant cardiovascular disorders
9. Bleeding disorders
10. Conditions interfering with X-ray or sputum assessment
11. Drug allergies/hypersensitivity to study medications
12. Pregnancy or breastfeeding
13. Positive drug screen (case-by-case assessment for some substances)
14. Serious mental disorders
15. Karnofsky score \<60
16. BMI \<16.0 kg/m²
17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
18. Pulmonary conditions other than TB (silicosis, fibrosis)
19. Active SARS-CoV-2 infection
20. Use of prohibited medications
21. Blood/plasma donation within 30 days
22. Current use of herbal remedies or traditional medicines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT07209761
Study Brief:
Protocol Section:
NCT07209761