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

April 18, 2023 updated by: Jae-Gook Shin, Inje University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jawa Timur
      • Surabaya, Jawa Timur, Indonesia, 60286
        • Recruiting
        • General Hospital Dr. Soetomo
        • Contact:
        • Principal Investigator:
          • Soedarsono Soedarsono, M.D., Ph.D.
    • Perum Grand
      • Gresik, Perum Grand, Indonesia, 61111
        • Recruiting
        • Ibnu Sina Hospital
        • Contact:
        • Principal Investigator:
          • Wiwik Kurnia illahi, M.D.
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Recruiting
        • Inje University Busan Paik Hoapital Clinical Trial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Outpatient and Inpatient who are diagnosed with Tuberculosis, Latent tuberculosis or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotics drugs.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum plasma concentration (Cmax)
Time Frame: Around 2 weeks or later after the first administration of antibiotics
Around 2 weeks or later after the first administration of antibiotics
Area under the plasma concentration versus time curve (AUC)
Time Frame: Around 2 weeks or later after the first administration of antibiotics
Around 2 weeks or later after the first administration of antibiotics
Development of population pharmacokinetic (PK) model of antibiotics
Time Frame: Through study completion, an average 3 years
The population pharmacokinetic properties of anti-TB drugs will be identified by plasma drug concentrations, pharmacogenomics genotypes, or clinical information. Population pharmacokinetic analysis will be performed by using NONMEN Ⅶ software. (ICON development solutions, Ellicott city, Maryland, USA)
Through study completion, an average 3 years
AUC/MIC
Time Frame: Through study completion, an average 3 years
If MIC data is available.
Through study completion, an average 3 years
Cmax/MIC
Time Frame: Through study completion, an average 3 years
If MIC data is available.
Through study completion, an average 3 years
Time above MIC (T > MIC)
Time Frame: Through study completion, an average 3 years
If MIC data is available.
Through study completion, an average 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N-acetyltransferase 2(NAT2) Pharmacogenetic analysis
Time Frame: baseline, pre-procedure
The six single nucleotide polymorphism (SNP) of NAT2, i.e., genotypes: rs1801279 for 191G>A, rs1041983 for 282C>T, rs1801280 341T>C, rs1799930 for 590G>A, rs1208 for 803A>G, and rs1799931 for 857G>A, will be analyzed with SNaPshot® kit (measurement tool) and categorized phenotypes of patients into rapid, intermediate, and slow acetylator.
baseline, pre-procedure
Solute carrier organic anion transporter family member 1B1(SLCO1B1) Pharmacogenetic analysis
Time Frame: baseline, pre-procedure
The two SNP of SLCO1B1, i.e., genotypes: rs2306283, rs4149056, will be analyzed with SNaPshot® kit and categorized phenotypes of patients into normal, intermediate, low transporter function.
baseline, pre-procedure
Biomarker exploration for adverse drug reaction
Time Frame: Through study completion, an average 3 years
Through study completion, an average 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Collaborators

Ministry of Science and ICT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2018

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

March 6, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cPMTb-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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