NCT05413551View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

March 23, 2023

Primary Completion Date

August 30, 2025

Study Completion Date

October 31, 2025

Conditions
Tuberculosis InfectionIsoniazid 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)

Trial Locations (1)

Unknown

RECRUITING

Federal University of Mato Grosso do Sul, Campo Grande

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Federal University of Mato Grosso

OTHER

collaborator

Fiocruz Mato Grosso do Sul

UNKNOWN

lead

Stanford University

OTHER