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Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention

NCT05413551 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-12-17

No results posted yet for this study

Summary

This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.

Conditions

  • Tuberculosis Infection
  • Isoniazid Adverse Reaction

Interventions

DRUG

Low-dose isoniazid

Pharmacogenomic-modified dose of isoniazid - 5 mg/kg oral tablet (maximum 300 mg)

DRUG

Standard dose of isoniazid

15 mg/kg oral tablet (up to 900 mg)

DRUG

High-dose isoniazid

Pharmacogenomic-modified dose of isoniazid - 25 mg/kg oral tablet (maximum 1500 mg)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Federal University of Mato Grosso

    collaborator OTHER

  • Fiocruz Mato Grosso do Sul

    collaborator UNKNOWN

  • Stanford University

    lead OTHER

Principal Investigators

  • Jason R Andrews, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2025-04-23
Completion
2025-06-25

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05413551 on ClinicalTrials.gov