TuberculosisNCT05280886
Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)
An observational study of Tuberculosis and Latent Tuberculosis, run by Inje University at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Latent Tuberculosis, Nontuberculous Mycobacterium Infection
- What is being tested?
- therapeutic drug monitoring(TDM)
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Jul 2018to 28 Feb 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatient and Inpatient who are diagnosed with Tuberculosis, Latent tuberculosis or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotics drugs.
Who may be able to join
- 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.
Who cannot join
- Children (minors) for whom the consent of a legal representative is impossible.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Indonesia2 sites, 2 recruiting
- Recruiting
Ibnu Sina Hospital
Gresik, Perum Grand, 61111
Wiwik Kurnia illahi, M.D., 08165423476, wiwikkurniaillahi@gmail.com
Wiwik Kurnia illahi, M.D.
- Recruiting
General Hospital Dr. Soetomo
Surabaya, East Java, 60286
Soedarsono Soedarsono, M.D., Ph.D., +62-811-3446-702, ssoedarsono@gmail.com
Soedarsono Soedarsono, M.D., Ph.D.
South Korea1 site, 1 recruiting
- Recruiting
Inje University Busan Paik Hoapital Clinical Trial Center
Busan, 614-735
JaeGook Shin, M.D., Ph.D., 82-51-890-6709, phshinjg@gmail.com
JaeGook Shin, M.D., Ph.D.
About this study
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.
- Being tested
- therapeutic drug monitoring(TDM)
- Keywords
- TB, Latent Tuberculosis Infection (LTBI), NTM
- Medical subject headings
- Tuberculosis, Latent Tuberculosis, Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic drug monitoring(TDM)Procedure or surgery
Based on this data, population pharmacokinetic models of antibiotics drugs that can be applicable to TDM will be developed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax)
Measured: Around 2 weeks or later after the first administration of antibiotics
Area under the plasma concentration versus time curve (AUC)
Measured: 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)
Measured: Through study completion, an average 3 years
AUC/MIC
If MIC data is available.
Measured: Through study completion, an average 3 years
Cmax/MIC
If MIC data is available.
Measured: Through study completion, an average 3 years
Time above MIC (T > MIC)
If MIC data is available.
Measured: Through study completion, an average 3 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: baseline, pre-procedure
Biomarker exploration for adverse drug reaction
Measured: Through study completion, an average 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start24 Jul 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Responsible party
- Principal investigator, Jae-Gook Shin, Inje University
- Investigators
- JaeGook JaeGook, Study chair, In-Je University PharmacoGenomics Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280886
- Sponsor's protocol ID
- cPMTb-001
- Status last verified
- Apr 2023
- First submitted
- 25 Jan 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seo WJ, Koo HK, Kang JY, Kang J, Park SH, Kang HK, Park HK, Lee SS, Choi S, Jang TW, Shin KC, Oh JY, Choi JY, Min J, Choi YK, Shin JG, Cho YS. Risk adjustment model for tuberculosis compared to non-tuberculosis mycobacterium or latent tuberculosis infection: Center for Personalized Precision Medicine of Tuberculosis (cPMTb) cohort database. BMC Pulm Med. 2023 Nov 24;23(1):471. doi: 10.1186/s12890-023-02646-7.
PubMed 38001469Soedarsono S, Jayanti RP, Mertaniasih NM, Kusmiati T, Permatasari A, Indrawanto DW, Charisma AN, Lius EE, Yuliwulandari R, Quang Hoa P, Ky Phat N, Thu VTA, Ky Anh N, Ahn S, Phuoc Long N, Cho YS, Shin JG. Development of population pharmacokinetics model and Bayesian estimation of rifampicin exposure in Indonesian patients with tuberculosis. Tuberculosis (Edinb). 2023 Mar;139:102325. doi: 10.1016/j.tube.2023.102325. Epub 2023 Feb 14.
PubMed 36841141
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)
- ClinicalTrials.gov ID
- NCT05280886
- Acronym / sponsor ID
- cPMTb-001
- Keywords
- TB, Latent Tuberculosis Infection (LTBI), NTM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatient and Inpatient who are diagnosed with Tuberculosis, Latent tuberculosis or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotics drugs.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Children (minors) for whom the consent of a legal representative is impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic drug monitoring(TDM)Based on this data, population pharmacokinetic models of antibiotics drugs that can be applicable to TDM will be developed. | Procedure or surgery | – |
Primary outcome
The 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
Time frame: 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)
AUC/MIC
Time frame: Through study completion, an average 3 years
If MIC data is available.
Cmax/MIC
Time frame: Through study completion, an average 3 years
If MIC data is available.
Time above MIC (T > MIC)
Time frame: Through study completion, an average 3 years
If MIC data is available.
3 secondary outcomes
N-acetyltransferase 2(NAT2) Pharmacogenetic analysis
Time frame: baseline, pre-procedure
Solute carrier organic anion transporter family member 1B1(SLCO1B1) Pharmacogenetic analysis
Time frame: baseline, pre-procedure
Biomarker exploration for adverse drug reaction
Time frame: Through study completion, an average 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 38001469Seo WJ, Koo HK, Kang JY, Kang J, Park SH, Kang HK, Park HK, Lee SS, Choi S, Jang TW, Shin KC, Oh JY, Choi JY, Min J, Choi YK, Shin JG, Cho YS. Risk adjustment model for tuberculosis compared to non-tuberculosis mycobacterium or latent tuberculosis infection: Center for Personalized Precision Medicine of Tuberculosis (cPMTb) cohort database. BMC Pulm Med. 2023 Nov 24;23(1):471. doi: 10.1186/s12890-023-02646-7.
- Derived from this study: PubMed 36841141Soedarsono S, Jayanti RP, Mertaniasih NM, Kusmiati T, Permatasari A, Indrawanto DW, Charisma AN, Lius EE, Yuliwulandari R, Quang Hoa P, Ky Phat N, Thu VTA, Ky Anh N, Ahn S, Phuoc Long N, Cho YS, Shin JG. Development of population pharmacokinetics model and Bayesian estimation of rifampicin exposure in Indonesian patients with tuberculosis. Tuberculosis (Edinb). 2023 Mar;139:102325. doi: 10.1016/j.tube.2023.102325. Epub 2023 Feb 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JaeGook JaeGook study chair
In-Je University PharmacoGenomics Research Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Latent Tuberculosis, run by Inje University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JaeGook Shin (+82-51-890-6709, phshinjg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum plasma concentration (Cmax) (time frame: Around 2 weeks or later after the first administration of antibiotics). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.