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

Sponsor
Inje University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05280886
Collaborator
Ministry of Science and ICT (Other)
5,000
1
79.2
63.1

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
  • Procedure: therapeutic drug monitoring(TDM)

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)
Actual Study Start Date :
Jul 24, 2018
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Feb 28, 2025

Outcome Measures

Primary Outcome Measures

  1. The maximum plasma concentration (Cmax) [Around 2 weeks or later after the first administration of antibiotics]

  2. Area under the plasma concentration versus time curve (AUC) [Around 2 weeks or later after the first administration of antibiotics]

  3. 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)

  4. AUC/MIC [Through study completion, an average 3 years]

    If MIC data is available.

  5. Cmax/MIC [Through study completion, an average 3 years]

    If MIC data is available.

  6. Time above MIC (T > MIC) [Through study completion, an average 3 years]

    If MIC data is available.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. Biomarker exploration for adverse drug reaction [Through study completion, an average 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.
Responsible Party:
Jae-Gook Shin, Director of Center, Inje University
ClinicalTrials.gov Identifier:
NCT05280886
Other Study ID Numbers:
  • cPMTb-001
First Posted:
Mar 15, 2022
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jae-Gook Shin, Director of Center, Inje University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022