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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT06191692
Eligibility Criteria:
Inclusion Criteria:
* Household contacts of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiated treatment with residence in the intervention areas;
* Positive QFT-Plus or TST results (TST induration of at least 5mm)
* Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designed area for the duration of the study;
* Age ≥ 18 years;
* Capable of providing signed informed consent;
* Willing to participate in the study visits and procedures
Exclusion Criteria:
* Indeterminate results on QFT-Plus;
* Clinical or radiographic suspicions or history of previous active TB;
* Known hypersensitivity or contraindication to any components of the regimens;
* Weight \<30kg;
* Acute or chronic liver failure with elevated liver enzymes or evidence of liver dysfunction such as jaundice or a history of liver failure caused by isoniazid or rifampicin; History of liver cirrhosis at any time before study entry;
* Infection with suspected or confirmed tuberculosis strains resistant to isoniazid or rifampicin;
* Porphyria- Porphyrin metabolism disorder;
* Polyneuropathy (self-reported/ confirmed);
* Pregnant or planning to become pregnant within 120 days of enrollment;
* Any other severe underlying condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial;
* Participation in other clinical intervention trials or research protocols (participation in other studies that do not involve an intervention may be allowed, but this must be discussed and approved by the Chief Investigator).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06191692
Study Brief:
Protocol Section:
NCT06191692