Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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 [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)
- AUC/MIC [Through study completion, an average 3 years]
If MIC data is available.
- Cmax/MIC [Through study completion, an average 3 years]
If MIC data is available.
- Time above MIC (T > MIC) [Through study completion, an average 3 years]
If MIC data is available.
Secondary Outcome Measures
- N-acetyltransferase 2(NAT2) Pharmacogenetic analysis [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.
- Solute carrier organic anion transporter family member 1B1(SLCO1B1) Pharmacogenetic analysis [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.
- Biomarker exploration for adverse drug reaction [Through study completion, an average 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with Tuberculosis.
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Latent tuberculosis, or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotic drugs.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inje University Busan Paik Hoapital Clinical Trial Center | Busan | Korea, Republic of | 614-735 |
Sponsors and Collaborators
- Inje University
- Ministry of Science and ICT
Investigators
- Study Chair: JaeGook JaeGook, In-Je University PharmacoGenomics Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- cPMTb-001