Health Condition 1: A150- Tuberculosis of lung Health Condition 2: A154- Tuberculosis of intrathoracic lymph nodes Health Condition 3: A155- Tuberculosis of larynx, trachea and bronchus Health Condition 4: A157- Primary respiratory tuberculosis Health Condition 5: A158- Other respiratory tuberculosis Health Condition 6: A159- Respiratory tuberculosis unspecified Health Condition 7: A180- Tuberculosis of bones and joints Health Condition 8: A181- Tuberculosis of genitourinary system Health Condit
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Control Intervention1: NIL: NIL
Sponsors
Indian Council of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for TB patients: 1.Patients diagnosed with TB and comorbidities 2.TB and comorbidities patients aged 18-80 years 3.TB patients with INH-containing first-line ATT therapy 4.Patients who are willing to give informed consent Inclusion criteria for healthy controls: 1.Healthy individuals (18-80 years) without tuberculosis (TB) 2.Willing to give informed consent Inclusion criteria for T2DM patients: 1.Newly diagnosed diabetic patients 2.Willing to give informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for TB patients: 1.HIV positive patients 2.Patients with prior liver or renal disease 3.Patients with seriously ill conditions (eg: COVID 19 etc.,) or clinically unstable patients Exclusion criteria for healthy controls: 1.TB patients 2.HIV positive patients 3.Patients with prior renal or liver diseases 4.Patients with seriously ill conditions (eg: COVID 19 etc.,) or clinically unstable patients Exclusion criteria for T2DM patients: 1.TB patients 2.HIV positive patients 3.Patients with prior renal or liver diseases 4.Patients with seriously ill conditions (eg: COVID 19 etc.,) or clinically unstable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Effectiveness of NAT2 genotype-guided LFT monitoring strategy in early detection and prevention of AT-DILI in TB patients during the intensive phase of ATT. 2.Assessing incidence and severity of AT-DILI among NAT2 slow and intermediate acetylators under different LFT monitoring strategies. 3.Identification of metabolomic biomarkers that could serve as preemptive biomarkers of AT-DILI before and during ATT.Identifying the differences in metabolomic profiles between TB patients and healthy individuals, and between NAT2 slow and intermediate acetylators. 4.Identifying the longitudinal changes in metabolomic profiles during the intensive phase of ATT and their correlation with AT-DILI and TB treatment outcomes. Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Impact of NAT2-genotype-based LFT monitoring strategies and metabolomic biomarkers on TB treatment outcomes, including ATT treatment interruptions, duration, and success rates. 2.Identify metabolomic signatures that could differentiate TB patients from TB patients having T2DM at baseline. Also, identify if these distinct metabolome profiles correlate with AT-DILI and other TB treatment outcomes. Timepoint: 3 years | — |
Countries
India
Contacts
Public ContactDr. Mahadev Rao
Manipal Academy of Higher Education
Outcome results
None listed