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A Study to Understand How Malnutrition and Genetics Affect Tuberculosis Medication Levels in the Blood.

Assessment of Altered Pharmacokinetics of Isoniazid and Rifampicin in Malnourished Pulmonary TB Patients and its Association with Acetylator Phenotype

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/07/113459
Enrollment
150
Registered
2026-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: Nil: Nil

Sponsors

Dr Shipra Anand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients diagnosed with pulmonary tuberculosis either microbiologically confirmed or clinically diagnosed according to NTEP guidelines who are malnourished with BMI less than 18.5 for malnourished group and greater than 18.5 for the control group Patients who have been on standard first-line anti TB treatment for at least 2 weeks Patients who can provide informed consent

Exclusion criteria

Exclusion criteria: Pregnant or lactating women Patients with HIV co-infection Patients with multi-drug-resistant TB Patients unable to comply with the study procedures

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of isoniazid and rifampicinTimepoint: 2 hours after the last dose of medications, assessed in patients who have been on standard therapy for at least 2 weeks.

Secondary

MeasureTime frame
Acetylator phenotype slow, intermediate, or fast assessed via the ration of acetyl isoniazid and isoniazid and NAT2 genotyping.Timepoint: 2 hours after the last dose of medications, assessed in patients who have been on standard therapy for at least 2 weeks.

Countries

India

Contacts

Public ContactDr Shipra Anand

Lok Nayak Hospital, Maulana Azad Medical College

shiprapulmonary@gmail.com7838703907

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026