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

NCT ID: NCT05280886

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-24

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis Latent Tuberculosis Nontuberculous Mycobacterium Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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therapeutic drug monitoring(TDM)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and ICT, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role lead

Responsible Party

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Jae-Gook Shin

Director of Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JaeGook JaeGook

Role: STUDY_CHAIR

In-Je University PharmacoGenomics Research Center

Locations

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General Hospital Dr. Soetomo

Surabaya, East Java, Indonesia

Site Status RECRUITING

Ibnu Sina Hospital

Gresik, Perum Grand, Indonesia

Site Status RECRUITING

Inje University Busan Paik Hoapital Clinical Trial Center

Busan, , South Korea

Site Status RECRUITING

Countries

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Indonesia South Korea

Central Contacts

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JaeGook Shin

Role: CONTACT

+82-51-890-6709

Facility Contacts

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Soedarsono Soedarsono, M.D., Ph.D.

Role: primary

+62-811-3446-702

Wiwik Kurnia illahi, M.D.

Role: primary

08165423476

JaeGook Shin, M.D., Ph.D.

Role: primary

82-51-890-6709

References

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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.

Reference Type DERIVED
PMID: 38001469 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36841141 (View on PubMed)

Other Identifiers

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cPMTb-001

Identifier Type: -

Identifier Source: org_study_id

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