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

NCT05280886 | Unknown

• 1 other identifier: cPMTb-001
• Study Type: observational
• Target: 5,000
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

TB; Latent Tuberculosis Infection (LTBI); NTM

Outcome Measures

Primary Outcomes (6)

• The maximum plasma concentration (Cmax)

  Around 2 weeks or later after the first administration of antibiotics

• Area under the plasma concentration versus time curve (AUC)

  Around 2 weeks or later after the first administration of antibiotics

• Development of population pharmacokinetic (PK) model of antibiotics

  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

  If MIC data is available.

  Through study completion, an average 3 years

• Cmax/MIC

  If MIC data is available.

  Through study completion, an average 3 years

• Time above MIC (T > MIC)

  If MIC data is available.

  Through study completion, an average 3 years

Secondary Outcomes (3)

• N-acetyltransferase 2(NAT2) Pharmacogenetic analysis

  baseline, pre-procedure

• Solute carrier organic anion transporter family member 1B1(SLCO1B1) Pharmacogenetic analysis

  baseline, pre-procedure

• Biomarker exploration for adverse drug reaction

  Through study completion, an average 3 years

Interventions

therapeutic drug monitoring(TDM) PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Inje University: lead
• Ministry of Science and ICT, Republic of Korea: collaborator

Study Sites (3)

General Hospital Dr. Soetomo

Surabaya, East Java, 60286, Indonesia

RECRUITING

Ibnu Sina Hospital

Gresik, Perum Grand, 61111, Indonesia

RECRUITING

Inje University Busan Paik Hoapital Clinical Trial Center

Busan, 614-735, South Korea

RECRUITING

Related Publications (2)

• Seo WJ, Koo HK, Kang JY, Kang J, Park SH, Kang HK, Park HK, Lee SS, Choi S, Jang TW, Shin KC, Oh JY, Choi JY, Min J, Choi YK, Shin JG, Cho YS. Risk adjustment model for tuberculosis compared to non-tuberculosis mycobacterium or latent tuberculosis infection: Center for Personalized Precision Medicine of Tuberculosis (cPMTb) cohort database. BMC Pulm Med. 2023 Nov 24;23(1):471. doi: 10.1186/s12890-023-02646-7.

  PMID: 38001469 DERIVED

• Soedarsono S, Jayanti RP, Mertaniasih NM, Kusmiati T, Permatasari A, Indrawanto DW, Charisma AN, Lius EE, Yuliwulandari R, Quang Hoa P, Ky Phat N, Thu VTA, Ky Anh N, Ahn S, Phuoc Long N, Cho YS, Shin JG. Development of population pharmacokinetics model and Bayesian estimation of rifampicin exposure in Indonesian patients with tuberculosis. Tuberculosis (Edinb). 2023 Mar;139:102325. doi: 10.1016/j.tube.2023.102325. Epub 2023 Feb 14.

  PMID: 36841141 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Plasma, Dried Blood Spot(DBS)

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis; Mycobacterium Infections, Nontuberculous

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• JaeGook JaeGook

  In-Je University PharmacoGenomics Research Center

  STUDY CHAIR

Central Study Contacts

JaeGook Shin

CONTACT

+82-51-890-6709; phshinjg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 15, 2022
• Study Start: July 24, 2018
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); ID (2)