Clinical trial NCT05280886: Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)
Official title: Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Latent Tuberculosis
Nontuberculous Mycobacterium Infection
Keywords: TB
Latent Tuberculosis Infection (LTBI)
NTM
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and ICT, Republic of Korea
First posted: 2022-03-15
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient and Inpatient who are diagnosed with Tuberculosis, Latent tuberculosis or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotics drugs.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The maximum plasma concentration (Cmax)
timeFrame: Around 2 weeks or later after the first administration of antibiotics
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Around 2 weeks or later after the first administration of antibiotics
measure: Development of population pharmacokinetic (PK) model of antibiotics
timeFrame: Through study completion, an average 3 years
measure: AUC/MIC
timeFrame: Through study completion, an average 3 years
measure: Cmax/MIC
timeFrame: Through study completion, an average 3 years
measure: Time above MIC (T > MIC)
timeFrame: Through study completion, an average 3 years
Secondary outcomes:
measure: N-acetyltransferase 2(NAT2) Pharmacogenetic analysis
timeFrame: baseline, pre-procedure
measure: Solute carrier organic anion transporter family member 1B1(SLCO1B1) Pharmacogenetic analysis
timeFrame: baseline, pre-procedure
measure: Biomarker exploration for adverse drug reaction
timeFrame: Through study completion, an average 3 years
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: General Hospital Dr. Soetomo
state: Jawa Timur
city: Gresik
country: Indonesia
facility: Ibnu Sina Hospital
state: Perum Grand
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hoapital Clinical Trial Center
Study officials:
affiliation: In-Je University PharmacoGenomics Research Center
name: JaeGook JaeGook
role: STUDY_CHAIR
References: