NCT05280886

Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Based on the collected antibiotic concentration data and individual patient's clinical information, a pharmacokinetic analysis report that can be applied for dose adjustment of the individual patient is provided. The pharmacokinetic/pharmacodynamic index using the minimum inhibition concentration (MIC) of the antibiotic obtained from the patient's clinical isolate is also explored. Utilizing these, we intend to establish a population pharmacokinetic model of antibiotics prescribed in treating Tuberculosis and Nontuberculous mycobacteria (NTM). The developed population pharmacokinetic model can be applied for therapeutic drug monitoring (TDM) based on dose adjustment through the obtained pharmacokinetic parameters.

Conditions

• Tuberculosis
• Latent Tuberculosis
• Nontuberculous Mycobacterium Infection

Interventions

Type	Name	Description
PROCEDURE	therapeutic drug monitoring(TDM)	Based on this data, population pharmacokinetic models of antibiotics drugs that can be applicable to TDM will be developed.

Timeline

• Start date: 2018-07-24
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2022-03-15
• Last updated: 2023-04-19

Locations

3 sites across 2 countries: Indonesia, South Korea