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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Based on this data, population pharmacokinetic models of antibiotics drugs that can be applicable to TDM will be developed.
General Hospital Dr. Soetomo
Surabaya, East Java, Indonesia
RECRUITINGIbnu Sina Hospital
Gresik, Perum Grand, Indonesia
RECRUITINGInje University Busan Paik Hoapital Clinical Trial Center
Busan, South Korea
RECRUITINGThe maximum plasma concentration (Cmax)
Time frame: Around 2 weeks or later after the first administration of antibiotics
Area under the plasma concentration versus time curve (AUC)
Time frame: 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)
Time frame: Through study completion, an average 3 years
AUC/MIC
If MIC data is available.
Time frame: Through study completion, an average 3 years
Cmax/MIC
If MIC data is available.
Time frame: Through study completion, an average 3 years
Time above MIC (T > MIC)
If MIC data is available.
Time frame: Through study completion, an average 3 years
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.
Time frame: 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.
Time frame: baseline, pre-procedure
Biomarker exploration for adverse drug reaction
Time frame: Through study completion, an average 3 years
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