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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT03783728
Eligibility Criteria:
Inclusion Criteria:
\- Age 18 years + 1 day (defined as date of birth plus one day). This age cutoff has been selected as tstin3d.com has only been validated for this age group.
Subjects must have all of the following:
* Untreated Latent Tuberculosis Infection (LTBI), defined as positive Tuberculin skin test/QuantiFERON TB Gold test or T-spot assay done within 1 month prior to enrollment.
* Absence of active TB disease as determined by history, physical examination, chest X-ray, (sputum smear and/or culture done as needed by the assessing physician for Mtb).
* Greater than 10% cumulative risk of developing active TB disease (determined by TSTin3D.com).
Exclusion Criteria:
* A subject will be excluded if any of the following criteria are met:
* Presence of active TB disease
* BMI \<16
* Cardiovascular instability (Blood pressure: Systolic \>180 or \<90 mm/Hg or Diastolic \>100 or \< 50mm/Hg; pulse \<40 or \>110)
* Chest X-Ray report within last 3 months not available
* HIV positive and currently on treatment with a regimen that has severe drug interactions with 3HP.
* Presumed infected with INH or Rifapentine (RIF)-resistant M. tuberculosis
* Women who are pregnant, nursing or expect to become pregnant for the duration of the study.
* Temperature ≥38.5°C or other clinical evidence of an acute infection at screening
* History of treatment for \>14 consecutive days with a rifamycin or \>30 consecutive days with isoniazid during the previous 2 years
* Documented history of completing adequate treatment for active tuberculosis or latent M. tuberculosis infection in a HIV-seronegative person
* History of sensitivity/intolerance to isoniazid or rifamycins
* Serum aspartate aminotransferase (AST) \>5 times the upper limit of normal (ULN) if AST was determined
* Hemodynamic instability or medical/psychological condition precluding participation in the study as judged by the investigator
* No access to a smartphone for personal use
* Refuse blood draws
* Refuse to participate in the study
* If female of childbearing potential and on a hormonal contraception method, refuse to use an additional barrier method with the hormonal method for the duration of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03783728
Study Brief:
Protocol Section:
NCT03783728