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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT00002104
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Positive AFB smear and/or culture for Mycobacterium tuberculosis, M. avium, or other mycobacterial infection, with or without documented HIV infection. NOTE:
* HIV-positive patients must have CD4 count \< 500 cells/mm3 and be on antiretroviral therapy.
* One of the following manifestations:
* Temperature over 38 C on at least two occasions in the week prior to study entry.
* Recent weight loss of more than 5 kilograms.
* Pulmonary involvement of one or more lobes or involvement of other tissues due to tuberculosis or other mycobacterial infections, or symptomatic infections related to HIV status.
* Night sweats on two or more occasions in the week prior to study entry.
NOTE:
* Patients must be hospitalized men aged 18-65 and postmenopausal women to age 65. Anticipated requirement for hospitalization must be at least 10 days.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Neuropathy or other disorders with risk of neuropathy.
Required for HIV-positive patients if CD4 count \< 500 cells/mm3:
* Antiretroviral therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00002104
Study Brief:
Protocol Section:
NCT00002104