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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT04670120
Eligibility Criteria:
Inclusion Criteria:
* (Those who must meet all the selection criteria can enter the group)
1. People who volunteer to participate in this trial and sign an informed consent form;
2. The range of the age is from 18 to 65 years old, regardless of gender;
3. The weight range of the patient who wear lightweight clothing and no shoes is from 40 to 90 Kg;
4. The patient is diagnosed with (initial treatment) tuberculosis, and the untreated sputum smear is 2+ or 2 times 1+ or more;
5. Chest x-ray examination results are consistent with tuberculosis;
6. Molecular tests show positive for Mycobacterium tuberculosis (e.g. GeneXpert or Hain) or positive for sputum culture;
7. Women in the reproductive period have a negative urine pregnancy test and agree to use high-efficiency contraception during the study period;
8. Male patients must agree to use appropriate contraceptive methods.
Exclusion Criteria:
* (Meet any of the following criteria will be excluded)
1. Those who cannot tolerate treatment delay;
2. Those who have used any drugs that are effective against Mycobacterium tuberculosis within 3 months before screening;
3. History of allergy to clofazimine, rifamycin and its derivatives, isoniazid, pyrazinamide or ethambutol;
4. Use any drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 30 days before administration (Including but not limited to quinidine, tyramine, ketoconazole, fluconazole, testosterone, quinine, progesterone, Methitione, phenpromazine, doxorubicin, trilithomycin, erythromycin, cocaine, furanilide, cimetidine, dextromethorphan);
5. Resistance to isoniazid and rifampicin;
6. Any disease or symptom that contradicts the use of rifampicin, isoniazid, pyrazinamide or ethambutol;
7. Severe extrapulmonary tuberculosis (blood disseminated tuberculosis, digestive system tuberculosis, genitourinary tuberculosis, bone and joint tuberculosis, tuberculosis meningitis, etc.);
8. There is evidence of silicosis, pulmonary fibrosis or other lung diseases considered by researchers to be serious (except tuberculosis);
9. The patient has chronic obstructive pulmonary disease or asthma;
10. Any clinically relevant concomitant circumstances or renal impairment characterized by serum creatinine level ≥1.5xULN, or liver damage with ALT and/or AST level ≥3×ULN and/or GGT level ≥3×ULN within the laboratory reference range;
11. History of alcohol abuse \[weekly alcohol intake is greater than 21 units/week (male) and 14 units/week (female) (1 unit=360mL beer; or 150mL glucose wine; or 45mL white wine)\], or the subject is unwilling to stop drinking from 24 hours before the start of the study to the end of the study, or had a positive alcohol breath test at the time of enrollment;
12. Subjects with liver, kidney, metabolism, autoimmune diseases, neurological, mental, blood system diseases, malignant tumors, long-term immunosuppressive agents;
13. People with a history of drug abuse or a positive urine drug screening;
14. Screening positive for hepatitis B, HIV, HCV virus and Treponema pallidum antibody;
15. Those who have a history of fainting needles and are judged to be clinically significant by the investigator;
16. Participated in clinical research of other drugs or devices three months before the start of the trial;
17. The subject has the following characteristics at the time of screening (according to the measurement and reading of the central electrocardiogram):
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1. The QT/QTc interval is significantly prolonged, for example, the QTcF (Fridericia correction) or QTcB (Bazett correction) interval is confirmed to be \>450 ms during screening;
2. Has a history of Ventricular tachycardia torsades de pointes, such as heart failure, hypokalemia, long QT syndrome, etc.;
3. Uses any drug known to extend the QTc interval 30 doses before the medication. (Not limited to amiodarone, bepridil, chloroquine, chlorpromazine, cisapride, cyclobenzaprine, clarithromycin, dipyrazine, doperidol, erythromycin, fluorine alcohol, Haloperidol, ibutilide, levamisole, methadone, mesalamide, pimozine, procaine, quinine, sotalol, sparfloxacin, thiazide);
4. The investigator judges that any ECG abnormalities of clinical significance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04670120
Study Brief:
Protocol Section:
NCT04670120