UnknownNot Applicable

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

Indonesia, South Korea5,000 participantsStarted 2018-07-24

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The maximum plasma concentration (Cmax)

Timeframe: Around 2 weeks or later after the first administration of antibiotics

Area under the plasma concentration versus time curve (AUC)

Timeframe: Around 2 weeks or later after the first administration of antibiotics

Development of population pharmacokinetic (PK) model of antibiotics

Timeframe: Through study completion, an average 3 years

AUC/MIC

Timeframe: Through study completion, an average 3 years

Cmax/MIC

Timeframe: Through study completion, an average 3 years

Time above MIC (T > MIC)

Timeframe: Through study completion, an average 3 years

Trial details

NCT IDNCT05280886

SponsorInje University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

Contact for this trial

JaeGook Shin

+82-51-890-6709 phshinjg@gmail.com

View on ClinicalTrials.gov More Tuberculosis trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The maximum plasma concentration (Cmax)

Timeframe: Around 2 weeks or later after the first administration of antibiotics

Area under the plasma concentration versus time curve (AUC)

Timeframe: Around 2 weeks or later after the first administration of antibiotics

Development of population pharmacokinetic (PK) model of antibiotics

Timeframe: Through study completion, an average 3 years

AUC/MIC

Timeframe: Through study completion, an average 3 years

Cmax/MIC

Timeframe: Through study completion, an average 3 years

Time above MIC (T > MIC)

Timeframe: Through study completion, an average 3 years