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Tailoring anti tuberculosis medication in children by checking drug blood levels in body.

Personalizing anti-tubercular medication in children using Therapeutic Drug Monitoring - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/076820
Enrollment
101
Registered
2024-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: A159- Respiratory tuberculosis unspecified

Interventions

Control Intervention1: Nil: Nil

Sponsors

Dr Mamta Muranjan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Receiving isoniazid as a component of anti-tuberculosis treatment or tuberculosis prophylaxis. 2. Patients should have received isoniazid for at least 7 continuous days

Exclusion criteria

Exclusion criteria: 1. Patient not willing to give assent/written informed consent for study. 2. Patients infected with non-tuberculous mycobacterium. 3. Patients having liver diseases (acute and chronic). 4. Patient taking any concomitant drug undergoing acetylation and affecting isoniazid metabolism (for example – dapsone, procainamide, clonazepam, sulfamethazine)

Design outcomes

Primary

MeasureTime frame
1. Determination of prevalence of fast acetylators in children receiving Isoniazid. 2. Classification of pediatric tuberculosis patients into slow and fast acetylators based on acetylator index status. 3.Determination of correlation between the acetylator index and plasma levels of INH at 2 and 6 hours post dose in children with TB. 4. Determination of the relationship between acetylator status and adverse drug reactions of isoniazid in children with TB. Timepoint: 12 months

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Vedant Gaikwad

Seth GS Medical College and KEM Hospital

vedantg1010@gmail.com8451889411

Outcome results

None listed

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