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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00788320
Eligibility Criteria:
Inclusion Criteria:
* Study subjects must be patients with newly diagnosed laboratory confirmed pulmonary tuberculosis (i.e., no previous history of treatment for TB for more than 30 days). Those enrolled should not have received more than 1 week of antituberculosis therapy prior to enrollment.
* Study subjects must agree to participate in the study and provide written informed consent
* Histology: not applicable
* Sites: Emory University affiliated hospitals (including Emory University Hospital, Emory Crawford Long Hospital, Grady Memorial Hospital), and metropolitan Atlanta health departments including the Fulton County Department of Health and Wellness and the DeKalb County Board of Health as well as additional health departments in the Metropolitan Atlanta area.
* Stage of Disease: pulmonary tuberculosis patients who have completed less than 1 week of TB therapy
* Age: Study subjects must be \> 18 years old
* Performance Status: study subjects will be patients with newly diagnosed laboratory confirmed pulmonary TB who have completed \< 1 week of anti-TB therapy and who are able to provide written informed consent
* Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English. An additional consent form will be provided to subjects who agree to long term storage of their blood, saliva, and sputum samples for future use by the investigators of this study. For subjects who do not speak English, a short consent form will be used to obtain informed consent, which will be available in the the 10 most commonly encountered languages in the greater Atlanta area after English. The short form will be used in conjunction with an interpreter who will assist in translating and discussing the content of the long form prior to the subjects' signing of the short form.
Exclusion Criteria:
* Age \< 18years
* Prior anti-microbial drug treatment of tuberculosis for longer than 1 week
* Prior other diseases: patients with prior disorders potentially affecting vitamin D levels and metabolism of calcium and phosphate will be excluded. Pregnant or lactating women are ineligible for this study. We plan to exclude patients with any known disorders of the endocrine system affecting vitamin D metabolism, including: hyperparathyroidism, known history of nephrolithiasis, any documented malignancies, and advanced renal disease. Patients with prior disorders that may potentially affect cathelicidin levels will be excluded as well. These diseases include atopic dermatitis (eczema) and hematologic malignancies (leukemia, lymphoma, among others)
* Infection: not applicable
* Hematologic, renal and hepatic, and other values that preclude entry into the study: serum creatinine of \>1.5 mg/dL to assist with exclusion of patients with renal disease. Patients with baseline calcium level \>10.5 mg/dL will be excluded to assist with exclusion of pre-existing disorders of vitamin D and calcium metabolism (see Section C above)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00788320
Study Brief:
Protocol Section:
NCT00788320