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 @ 3:43 AM
Ignite Modification Date:
2025-12-25 @ 3:43 AM
NCT ID:
NCT01611402
Eligibility Criteria:
* INCLUSION CRITERIA:
For all patients:
* Adults, age 18 or older
* TB diagnosis, ascertained as follows:
1. specimen or biopsy smear, culture, or PCR positivity or
2. compatible clinical presentation and imaging with strong suspicion for TB that necessitates initiation of empiric TB therapy (in which case the confirmation by culture or other laboratory means may follow enrollment, or alternatively clinical improvement in response to TB therapy may confirm the diagnosis).
If the TB diagnosis cannot be confirmed as above (i.e. culture positive for NTM), the patient will be excluded from final analysis.
* Ability and willingness of subject or legal guardian/representative to understand study requirements and give informed consent. In the event an adult subject is unable, due to illness or mental incapacity, to give informed consent, a person authorized with durable power of attorney (DPA) or legal guardian may give consent for the subject s blood to be obtained, shipped, and tested under this protocol.
* Agree to storage of study data and biologic specimens for use in future studies of immune function, tuberculosis, genetics, and/or HIV pathogenesis.
Patients in TB mono-infected arm (Group A) would additionally be eligible if:
* HIV negative (documented seronegative within 1 month of study visit)
* Not receiving TB therapy for more than 7 days prior to study visit (Group A1) or
* Currently on TB therapy for \>7 days and \< 5 months (Group A2)
Patients in TB/HIV co-infected arm (Group B) would additionally be eligible if:
* HIV positive (outside HIV testing will be accepted)
* Not receiving TB therapy for more than 7 days prior to study visit
* Untreated or ART na(SqrRoot) ve (will be accepted if they had been on ART in the past but none within the last 6 months).
Patients in TB/HIV co-infected, treated arm (Group C) would additionally be eligible if:
* HIV positive
* Currently receiving TB therapy
* Currently receiving ART (The subset of patients without TB-IRIS will have been on antiretroviral therapy for at least 8 and not more than 12 weeks. The subset of patients with TB-IRIS will be enrolled at the time of their TB-IRIS event) with some evidence of adherence (often measured by clinical improvement, medication refills or laboratory values)
* The TB-IRIS subset of patients (15 patients at NIAID and 20 patients at SHAPHC) would also need to meet criteria for paradoxical TB-IRIS
EXCLUSION CRITERIA:
Pregnancy or post-partum period (6 months post-partum or while breast-feeding, whichever is longer).
Documented history of hemoglobin from most recent blood draw less than 7g/dL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01611402
Study Brief:
Protocol Section:
NCT01611402