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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00814827
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients must meet all of the following criteria at the time of evaluation to be eligible for enrollment into the study cohorts:
Group 1 (NTM alone):
1. Past or current infection with NTM proven by culture or specific DNA detection in the presence of a compatible clinical picture as judged by the responsible clinician and PI on site.
2. NTM is not felt to iatrogenic (such as indwelling catheter associated or post-operative wound infection)
3. HIV negative within 3 months either prior to the diagnosis of OI, or prior to enrollment in this study, if HIV status was unknown at the time of OI
4. No evidence of active malignancy
5. No systemic corticosteroids at time of diagnosis of OI (defined as greater than 4 weeks at a dose greater than 10 mg per day of prednisone within 3 months prior to diagnosis of the NTM)
6. No preexisting immune deficiency
Group 2 (non-NTM OI with or without NTM):
1. Patients must have or have had proven infection with one or more of the following organisms: disseminated Salmonella, Listeria, Penicillium, Burkholderia pseudomallei, Cryptococcus, Histoplasma, Herpes zoster involving 2 or more non-contiguous dermatomes, or extradermal involvement or other opportunistic infections not listed above, but relevant, as determined by the PI.
2. Patient may have infection with NTM in addition to one or more of the above infection(s).
3. HIV-negative within 3 months either prior to the diagnosis of OI, or prior to enrollment in this study, if HIV status was unknown at the time of OI diagnosis
4. No evidence of active malignancy
5. No systemic corticosteroids at time of diagnosis of OI (defined as greater than 4 weeks at a dose greater than 10 mg per day of prednisone within 3 months prior to diagnosis of the NTM)
6. No preexisting immune deficiency
Group 3 (diseased control with pulmonary MTB):
1. Active pulmonary MTB, i.e. patients who have sputum that is either culture positive for MTB or AFB positive and responding to therapy for MTB.
2. Diagnosed with the past 6 months.
3. No concurrent infections due to NTM or OI listed under above inclusion criteria for study subjects
4. No clinical evidence of HIV
Group 4 (diseased control with disseminated MTB):
Disseminated MTB includes infections involving greater than or equal to 2 noncontiguous sites, one of which may include pulmonary disease or greater than or equal to 2 separate groups of lymph nodes.
1. Active disseminated MTB or cured disseminated MTB
2. No concurrent infections due to NTM or OI listed under above inclusion criteria for study subjects
3. HIV negative within 3 months either prior to the diagnosis of MTB, or prior to enrollment in this study, if HIV status was unknown at the time of MTB diagnosis
4. No evidence of active malignancy
5. No systemic corticosteroids at time of diagnosis of OI (defined as \> 4 weeks at a dose \> 10 mg per day of prednisone within 3 months prior to diagnosis of the NTM)
6. No preexisting immune deficiency.
Group 5 (Blood Specimen Donors):
Eligibility criteria not applicable. Blood will be collected from volunteers, and no medical evaluation will be performed.
To be a blood donor the person cannot be excluded per the exclusionary criteria:
1. Patient \< 18 or \> 85
2. Weight \> 45 kg (99 lbs)
3. Receiving chemotherapy of have cancer
4. Receiving immunosuppressant medications
5. Have a history of heart, lung, kidney disease of bleeding disorder.
EXCLUSION CRITERIA:
Patients will be excluded for the following reasons:
1. HIV-positive serostatus for groups 1, 2 and 4 (groups 3 and 5 will not be routinely performing HIV testing)
2. Active malignancy
3. Medical conditions requiring immune modulating therapy (i.e. corticosteroids, biological agents, anti-metabolites) and /or chemotherapy
4. Any other medical conditions unsuitable for this study as determined by the principal investigator
5. Age less than 18 years
6. Receiving any other investigational study agents when enrolling on this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT00814827
Study Brief:
Protocol Section:
NCT00814827