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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT02821832
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Age 18 to 75 years with body weight from 35 kg to 90 kg
2. Has not been treated for active TB within the past 3 years
3. Not yet on TB treatment
4. Xpert positive for M.tb
5. Rifampin-sensitive pulmonary tuberculosis as indicated by Xpert
6. Laboratory parameters within previous 14 days before enrollment:
1. Serum AST and ALT \<3x upper limit of normal (ULN)
2. Creatinine \<2x ULN
3. Hemoglobin \>7.0 g/dL
4. Platelet count \>50 x10(9) cells/L
7. Able and willing to return for follow-up visits
8. Able and willing to provide informed consent to participate in the study
9. Willing to undergo an HIV test
10. At sites with sufficient SARS-CoV-2 testing capacity and personal protective equipment for study staff, willing to undergo COVID-19 testing:
viral RNA PCR testing for SARS-CoV-2 to determine active infection and antibody testing for SARS-CoV-2 to determine prior infection
11. Willing to have samples, including DNA, stored
12. Willing to consistently practice a highly reliable, non-hormonal method of pregnancy prevention (e.g., condoms) during treatment if participant is a premenopausal female unless she has had a hysterectomy or bilateral tubal ligation or her male partner has had a vasectomy. If hormonal contraception is used an additional method of pregnancy prevention (as above) should be used.
EXCLUSION CRITERIA:
1. Clinical suspicion of or confirmed extrapulmonary TB, including pleural TB
2. Pregnant or desiring/trying to become pregnant in the next 6 months or breastfeeding.
3. HIV infected
4. Currently COVID-19 infected
5. Unable to take oral medications
6. Diabetes as defined by point of care HbA1c greater than 6.5%, random glucose greater than 200 mg/dL (or 11.1 mmol/L), fasting plasma glucose greater than or equal to 126 mg/dL (or 7.0 mmol/L), or the presence of any antidiabetic agent (including traditional medicines) as a concomitant medicine
7. Disease complications or concomitant illnesses that may compromise safety or interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)
8. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks
9. Use of any investigational drug in the previous 3 months
10. Substance or alcohol abuse that in the opinion of the investigator may interfere with the participant's adherence to study procedures.
11. Any person for whom the physician feels this study is not appropriate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02821832
Study Brief:
Protocol Section:
NCT02821832