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| Name | Class |
|---|---|
| Ministry of Science and ICT, Republic of Korea | OTHER_GOV |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic drug monitoring(TDM) | Procedure | Based on this data, population pharmacokinetic models of antibiotics drugs that can be applicable to TDM will be developed. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 â…¦ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| N-acetyltransferase 2(NAT2) Pharmacogenetic analysis | 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Children (minors) for whom the consent of a legal representative is impossible.
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Outpatient and Inpatient who are diagnosed with Tuberculosis, Latent tuberculosis or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotics drugs.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JaeGook Shin | Contact | +82-51-890-6709 | phshinjg@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| JaeGook JaeGook | In-Je University PharmacoGenomics Research Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Dr. Soetomo | Recruiting | Surabaya | East Java | 60286 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38001469 | Derived | 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. | |
| 36841141 |
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Whole blood, Plasma, Dried Blood Spot(DBS)
| baseline, pre-procedure |
| Solute carrier organic anion transporter family member 1B1(SLCO1B1) Pharmacogenetic analysis | 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 | Through study completion, an average 3 years |
| Ibnu Sina Hospital | Recruiting | Gresik | Perum Grand | 61111 | Indonesia |
|
| Inje University Busan Paik Hoapital Clinical Trial Center | Recruiting | Busan | 614-735 | South Korea |
|
| 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. |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D055985 | Latent Tuberculosis |
| D009165 | Mycobacterium Infections, Nontuberculous |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
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