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

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT05280886

cPMTb-001

All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

July 24, 2018

February 28, 2025

Connect with a study center

General Hospital Dr. Soetomo
Surabaya, Jawa Timur 60286
Indonesia
Active - Recruiting
Ibnu Sina Hospital
Gresik, Perum Grand 61111
Indonesia
Active - Recruiting
Inje University Busan Paik Hoapital Clinical Trial Center
Busan, 614-735
Korea, Republic of
Active - Recruiting

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