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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280886
• Other study ID #: cPMTb-001
• Status: Recruiting
• Start date: July 24, 2018
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2023
• Source: Inje University
• Contact: JaeGook Shin
• Phone: +82-51-890-6709
• Email: phshinjg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Latent Tuberculosis
• Mycobacterium Infections
• Mycobacterium Infections, Nontuberculous
• Nontuberculous Mycobacterium Infection
• Tuberculosis

Intervention

Procedure:
• therapeutic drug monitoring(TDM)
Based on this data, population pharmacokinetic models of antibiotics drugs that can be applicable to TDM will be developed.

Locations

Country	Name	City	State
Indonesia	Ibnu Sina Hospital	Gresik	Perum Grand
Indonesia	General Hospital Dr. Soetomo	Surabaya	Jawa Timur
Korea, Republic of	Inje University Busan Paik Hoapital Clinical Trial Center	Busan

Sponsors (2)

Lead Sponsor	Collaborator
Inje University	Ministry of Science and ICT

Countries where clinical trial is conducted

Indonesia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum plasma concentration (Cmax)		Around 2 weeks or later after the first administration of antibiotics
Primary	Area under the plasma concentration versus time curve (AUC)		Around 2 weeks or later after the first administration of antibiotics
Primary	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 ? software. (ICON development solutions, Ellicott city, Maryland, USA)	Through study completion, an average 3 years
Primary	AUC/MIC	If MIC data is available.	Through study completion, an average 3 years
Primary	Cmax/MIC	If MIC data is available.	Through study completion, an average 3 years
Primary	Time above MIC (T > MIC)	If MIC data is available.	Through study completion, an average 3 years
Secondary	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.	baseline, pre-procedure
Secondary	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
Secondary	Biomarker exploration for adverse drug reaction		Through study completion, an average 3 years