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

NCT05280886 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2023-04-19

No results posted yet for this study

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

PROCEDURE

therapeutic drug monitoring(TDM)

Based on this data, population pharmacokinetic models of antibiotics drugs that can be applicable to TDM will be developed.

Sponsors & Collaborators

  • Ministry of Science and ICT, Republic of Korea

    collaborator OTHER_GOV
  • Inje University

    lead OTHER

Principal Investigators

  • JaeGook JaeGook · In-Je University PharmacoGenomics Research Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • Indonesia
  • South Korea

Study Locations

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Entities

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 NCT05280886 on ClinicalTrials.gov