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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT02225158
Eligibility Criteria:
* INCLUSION CRITERIA
All subjects must meet the following criteria:
* Subjects must have 1 of the following:
* Untreated LTBI, defined as positive Quantiferon TB Gold assay; absence of active TB disease as determined by history, physical examination, chest X-ray, and negative sputum smear and culture for Mtb; and no history of prior treatment for LTBI. OR
* Chronic inactive TB, defined as past history of documented or selfreported active pulmonary TB for which treatment was received; current negative sputum smear and culture for Mtb; and a positive result on the Quantiferon TB Gold assay. These subjects will compose the treatment-induced LTBI group and will not require treatment for LTBI.
* Age 18-70 years. Subjects over the age of 70 will not be included due to the increased potential for immune senescence
* With or without clinical/microbiologic/serologic evidence of untreated concurrent helminth infection
* Agree to have blood specimens stored for future studies
Subjects undergoing optional bronchoscopy and bronchoalveolar lavage must meet the following additional inclusion criteria:
* Subjects must have 1 of the following:
* Documented or self reported history of prior treated TB with positive Quantiferon TB Gold test and structural lung findings of chronic inactive tuberculosis on radiologic imaging, defined as: a) calcified Ghon focus with or without apical calcified nodules (Simon foci), b) parenchymal or pleural calcification, and/or c) apical fibrosis and cavitary changes. OR
* History of recent prolonged (greater than or equal to 3 months) exposure to a confirmed case of active TB disease.
* Able and willing to arrange to have another person drive them home after the procedure
* Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure
* Agree to have respiratory tract samples stored for future research
EXCLUSION CRITERIA
A subject will be excluded if they meet any of the following criteria:
* Presence of active TB disease
* Treatment for helminth infection within the past year
* Positive at screening for HIV, hepatitis B, and/or hepatitis C Cardiovascular instability (Blood pressure: Systolic \>180 or \<90 mm/Hg or Diastolic \>100 or \< 50 mm/Hg; pulse \<40 or \>110)
* Inadequate peripheral venous access
* Anemia (hemoglobin \<11 g/dL)
* Current use of corticosteroids or other immunosuppressive agents or documented diagnosis of a primary immunodeficiency disorder
* Underlying heart disease, lung disease, bleeding disorder, or other conditions that, in the judgment of the investigator, contraindicates apheresis
* Temperature greater than or equal to 38.5 degrees C or other clinical evidence of an acute infection at screening
* Currently pregnant or breastfeeding
A subject will not be eligible for optional bronchoscopy and bronchoalveolar lavage if they meet any of the following additional exclusion criteria:
* History of recent/acute clinically significant pulmonary compromise. This will be defined by the following criteria:
* New lung infection or change in status of chronic lung infection or significant new findings on chest X-ray or CT scan
* Asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that required the use of oral or parenteral corticosteroids during the past two years
* Clinically significant reactive airway disease that does not respond to bronchodilators
* Unstable chronic lung disease such as Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis
* History of pulmonary hypertension
* Requirement of supplemental oxygen at rest
* Unstable angina or uncontrolled heart failure or rhythm disturbance
* Significant kidney or liver disease
* Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with IM injections or blood draws, or use of anticoagulant medications
* Use of platelet inhibitors including aspirin and NSAIDs within 7 days of procedure or clopidogrel (Plavix \[TM\]) within 14 days of procedure or the inability to safely stop platelet inhibitors for 7-14 days prior to procedures
* History of allergic reaction to lidocaine, sedative medications like Valium(TM) or Versed (TM), or narcotic medications like morphine or fentanyl
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to bronchoscopy and bronchoalveolar lavage or impairs a volunteer s ability to give informed consent for the procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02225158
Study Brief:
Protocol Section:
NCT02225158