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Genomic Study for Determination of Precise dose of Isoniazid in TB Patients.

Integrating Pharmacogenomic and Population Pharmacokinetic Analysis for Precision Therapy of Isoniazid in TB Patients.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/05/019105
Enrollment
100
Registered
2019-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A19- Miliary tuberculosis Health Condition 2: A150- Tuberculosis of lung Health Condition 3: A17- Tuberculosis of nervous system Health Condition 4: A18- Tuberculosis of other organs

Interventions

None listed

Sponsors

Levin Thomas
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Patients diagnosed with TB. 2. Patients who are under minimum three days of Isoniazid therapy. 3. Age more than 18 years and less than 70 years. 4. Patients who are willing to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Vulnerable patients: Pregnant women and mentally challenged patients. 2. HIV positive patients.

Design outcomes

Primary

MeasureTime frame
Demographic characteristics, clinical presentations, biochemical reports, diagnostic results, treatment details, INH pharmacokinetic data and NAT2 genotyping.Timepoint: Demographic characteristics, clinical presentations, biochemical reports, diagnostic results, treatment details, INH pharmacokinetic data and NAT2 genotyping data will be assessed/evaluated after 3 years from the date of the start of the study.—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactLevin Thomas

Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education

mahadev.rao@manipal.edu8105706060

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026