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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT01071603
Eligibility Criteria:
* INCLUSION CRITERIA:
A subject must fulfill all inclusion criteria within his or her assigned cohort in order to be eligible to participate in this study.
Smear Positive TB (Cohort A)
* Age 18-65 years old
* Sputum AFB-smear positive (at least 1 positive smears out of 3) and exhibiting the signs or symptoms suggestive of pulmonary MTB disease
* If presently on anti-TB chemotherapy, having a regimen which started not more than 14 days prior to enrollment (please see note below)
* If previously treated for TB, having been off of anti-TB chemotherapy for at least 60 days before starting present regimen, or before enrollment if not presently on drugs
* Willingness to adhere to study visits and testing
* Willingness to have samples stored
Smear Negative TB (Cohort B)
* Age 18-65 years old
* Sputum AFB-smear negative (zero out of 3) and exhibiting the signs or symptoms suggestive of pulmonary MTB disease
* If presently on anti-TB chemotherapy, having a regimen which started not more than 14 days prior to enrollment (please see note below)
* If previously treated for TB, having been off of anti-TB chemotherapy for at least 60 days before starting present regimen, or before enrollment if not presently on drugs
* Willingness to adhere to study visits and testing
* Willingness to have samples stored
* Subjects with the above criteria who cannot expectorate and cannot produce sputum by induction
Extra Pulmonary TB (Cohort C)
* Age 18-65 years old
* Exhibiting the signs and symptoms suggestive of MTB EP disease
If presently on anti-TB chemotherapy, having a regimen which started not more than 14 days prior to enrollment (please see note below)
* If previously treated for TB, having been off of anti-TB chemotherapy for at least 60 days before starting present regimen, or before enrollment if not presently on drugs
* Willingness to adhere to study visits and testing
* Willingness to have samples stored
Controls (Cohort D):
* Age 18-65 years old
* No signs or symptoms of an active TB infection
* Willingness to adhere to study visit and testing
* Willingness to have samples stored
EXCLUSION CRITERIA:
A subject will be excluded from this study if he or she meets any of the following exclusion criteria from their assigned cohort. Also, potential participants may be excluded from the study on the basis of the investigator s judgment concerning the ability to comply with study procedures or posing an undue risk to the subject.
Cohort C Only
Evidence of pulmonary TB (If subject at enrollment is suspected to have both pulmonary TB and extrapulmonary TB, then s/he will be enrolled into Cohort A or B)
Cohort D (Controls)
* Those with signs or symptoms consistent with TB disease
* Women who report themselves to be pregnant or those found to be pregnant by a urine beta-HCG test during the protocol introduction and consent process;
* Those having a chest X-ray suggestive of active tuberculosis
* Use of immunosuppressive agents such as corticosteroids, TNF blocking agents, cyclosporine, methotrexate, or mycophenolate at entry
* Body mass index (BMI) \<16
* History of systemic lupus erythematosus, rheumatoid arthritis, or other connective tissue disease
* The use of any of the following drugs within 30 days prior to study or anticipated use of these drugs within the next 60 days:
* Systemic cancer chemotherapy
* Systemic corticosteroids
* Immune globulin
* Interleukins
* Interferons
* Those with malignancies
Cohort A-C Scan Exclusions
The following will still be included in the study; however they will be excluded from the CT scanning (enrollment and follow-up) only:
* Those who are pregnant
* Those with a creatinine greater than 150 UL within 14 days of a scheduled CT scan (enrollment or follow-up)
Note that if subjects excluded by these above criteria for a study-related CT scan still require a CT scan because of medical necessity, the results of the CT scan will be collected by the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01071603
Study Brief:
Protocol Section:
NCT01071603