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
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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UNKNOWN
5000 participants
OBSERVATIONAL
2018-07-24
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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.
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Ministry of Science and ICT, Republic of Korea
OTHER_GOV
Inje University
OTHER
Responsible Party
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Jae-Gook Shin
Director of Center
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
Ibnu Sina Hospital
Gresik, Perum Grand, Indonesia
Inje University Busan Paik Hoapital Clinical Trial Center
Busan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Other Identifiers
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cPMTb-001
Identifier Type: -
Identifier Source: org_study_id
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