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 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT04232618
Eligibility Criteria:
Inclusion Criteria:
1. Aged 12 to 70 years.
2. Symptoms suggestive of TB disease: cough for ≥ two weeks plus at least one of the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or loss of appetite.
3. Participants aged ≥18 years-old: Willing to give informed consent to take part in the study, including
1. Willingness to undergo HIV testing and be willing to have their HIV infection status disclosed to the study field workers.
2. Willingness to have study samples stored indefinitely.
4. Participants aged ≥12 and \<18 years:
1. Accompanied by a parent or legal guardian/caregiver/representative who is willing to provide informed consent for study procedures as above, and
2. The child is willing to give informed assent for study procedures as above and the attending research staff member is satisfied that the participant understands the study satisfactorily.
Participants who had previous TB, extra-pulmonary TB in addition to pulmonary TB, drug resistance detected on GeneXpert® Ultra or culture, or other concomitant diseases will not be excluded from enrolment. People living with, and without, HIV will be enrolled.
Exclusion Criteria:
1. Stable permanent residence in study area for less than 3 months; no permanent address or planned relocation in the next six months.
2. Pregnancy or breastfeeding.
3. Hb \< 9g/l.
4. Current systemic steroid use or immune suppression therapy in the past four weeks.
5. On TB treatment or Isoniazid Preventive Treatment (IPT) currently or in the last ninety days.
6. Known quinolone or aminoglycoside antibiotic use reported in the past 60 days.
7. Participants aged ≥18 years-old: Unable to provide informed consent (eg due to mental impairment), or are deemed by the attending research staff member as unable to complete study procedures (eg. due to substance abuse affecting the participant's level of function).
8. Participants aged ≥12 and \<18 years:
1. Either the parent/guardian is willing to give informed consent or the participant is unwilling to give informed assent.
2. Both the parent/guardian and the child are willing to provide consent and assent, but in the attending researcher's opinion there is a problem with the validity of the consent (eg. because of suspected mental impairment) or with completion of study procedures (eg. because of substance abuse of parent or child).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
70 Years
Study:
NCT04232618
Study Brief:
Protocol Section:
NCT04232618