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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT07058233
Eligibility Criteria:
Inclusion Criteria:
* Who had access to electronic devices (e.g., mobile phones) for adherence monitoring
* individuals newly diagnosed with rifampicin-resistant pulmonary tuberculosis (RR-TB), multidrug-resistant tuberculosis (MDR-TB), or pre-extensively drug-resistant tuberculosis (Pre-XDR-TB) at the drug-resistant tuberculosis outpatient clinic of Persahabatan General Hospital, Jakarta, Indonesia.
* BMI of 13-20 kg/m²
* had received standardized or individualized treatment regimens for seven days
* had no severe drug-induced hepatitis indicated by elevated liver enzymes \>5 times the normal upper limit
Exclusion Criteria:
* individuals with HIV infection,
* end-stage renal failure,
* severe anemia (hemoglobin \<8 g/dL),
* severe hypoalbuminemia (albumin \<2.5 g/dL),
* acute or chronic liver diseases (including hepatitis, cirrhosis, or jaundice),
* cancer,
* interstitial lung disease (ILD),
* anatomical gastrointestinal disorders (either congenital or post-surgical),
* diabetes mellitus,
* long-term corticosteroid or immunosuppressant therapy
* other acute pulmonary infections such as pneumonia,
* exacerbations of chronic obstructive pulmonary disease (COPD), or asthma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
65 Years
Study:
NCT07058233
Study Brief:
Protocol Section:
NCT07058233