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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01381757
Eligibility Criteria:
* INCLUSION CRITERIA:
Individuals (12 years of age) who meet the following criteria are eligible for enrollment in the study:
Have a sputum smear that is positive for acid-fast bacilli by microscopy or have clinical symptoms and abnormal findings compatible with active TB on a previously performed chest radiograph.
Have either completed at least 5 months of treatment with antituberculous therapy within the past year or have not received any antituberculous treatment in the preceding 5 years.
Willingness to provide a sputum sample for the study.
Ability to follow verbal instructions for producing sputum.
Willingness to undergo testing for HIV.
Willingness to allow storage of samples for future research.
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria are not eligible for enrollment in the study:
Any condition that in the investigator s opinion places the subject at undue risk by participating in the study.
Subjects younger than 12 years of age will be excluded from the study due to the difficulty of obtaining adequate sputum samples for the diagnosis of TB in this population and because there are no means for obtaining gastric aspirates at the reference centers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01381757
Study Brief:
Protocol Section:
NCT01381757