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

Inje University

Status: Enrolling

Conditions: Tuberculosis; Latent Tuberculosis; Nontuberculous Mycobacterium Infection

Treatments: Procedure: therapeutic drug monitoring(TDM)

Study type: Observational

Funder types: Other

Identifiers

NCT05280886

cPMTb-001

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with Tuberculosis.
• Latent tuberculosis, or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotic drugs.
• Patients who understand and voluntarily sign an informed consent form before any study-related procedures are conducted.

Exclusion criteria

• Children (minors) for whom the consent of a legal representative is impossible.