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 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT05981495
Eligibility Criteria:
Inclusion Criteria:
* Children and adults aged two years or older (including older adults that are 65+)
* Ability and willingness to provide informed consent/assent/permission, and a parent/legal guardian willing to give consent on the child's behalf for study participants aged 2-17 years
* Ability and willingness to perform study procedures, or parent/legal guardian to provide consent for a child to undergo study procedures on their behalf (when applicable)
* Clinical signs and symptoms typically associated with active TB disease including, but not limited to:
Cough for \> two (2) weeks Lethargy, weakness, malaise Reduced playfulness (pediatric population) Weight loss or loss of appetite Failure to thrive (pediatric population) Fever Chest pain Night sweats
* Physician (or healthcare provider) suspicion of TB disease
Exclusion Criteria:
* Pregnancy (based on participant-provided information)
* Any physical or mental health condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject and/or prevent, limit, or confound protocol-specified procedures
* Critical illness needing immediate medical care
* Receipt of treatment for active TB or LTBI in the past 24 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT05981495
Study Brief:
Protocol Section:
NCT05981495