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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT06845618
Eligibility Criteria:
Inclusion Criteria:
Participants with a new diagnosis of tuberculosis
* Aged ≥ 18 years old
* Newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of Mycobacterium tuberculosis (Mtb.) infection (of any site)
* Has not yet commenced antituberculosis therapy
* Able to understand study procedures and requirements and is able to give informed consent
For healthy volunteers:
* Aged ≥ 18 years old
* Healthy as judged by a responsible physician
* Able to understand study procedures and requirements and is able to give informed consent
Exclusion Criteria:
Participants with a new diagnosis of tuberculosis
* Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone)
* Known history of underlying malignancy
* Pregnancy
* Transfusion dependent anaemia
For healthy volunteers:
* History of tuberculosis infection or latent tuberculosis infection
* Household, or other close contact, of a person living with tuberculosis disease
* Chest radiograph (CXR) changes suggestive of pulmonary tuberculosis
* Presence of symptoms which would otherwise indicate screening for tuberculosis (cough \> 2 weeks duration, fever, weight loss, night sweats)
* Other major medical comorbidity
* Pregnancy
* Known malignancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06845618
Study Brief:
Protocol Section:
NCT06845618