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Multi-site Cohort study for the development of personalized pharmacotherapy in patients with Tuberculosis or Nontuberculous mycobacterial disease

Multi-site Cohort study for the development of personalized pharmacotherapy in patients with Tuberculosis or Nontuberculous mycobacterial disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0006985
Enrollment
5000
Registered
2022-02-07
Start date
2018-07-24
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Inje University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with Tuberculosis, Latent tuberculosis, or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotic drugs. 2) Patients who understand and voluntarily sign an informed consent form before any study-related procedures are conducted.

Exclusion criteria

Exclusion criteria: 1) children (minors) for whom the consent of a legal representative is impossible

Design outcomes

Primary

MeasureTime frame
The maximum plasma concentration (Cmax);Area under the plasma concentration versus time curve (AUC);Development of population pharmacokinetic (PK) model of antibiotics;AUC/MIC;Cmax/MIC;T > MIC—

Secondary

MeasureTime frame
N-acetyltransferase 2(NAT2) Pharmacogenetic analysis ;Solute carrier organic anion transporter family member 1B1 (SLCO1B1) Pharmacogenetic analysis;Biomarker exploration for adverse drug reaction—

Countries

Korea, Republic of

Contacts

Public ContactJae-Gook Shin

Inje University Busan Paik Hospital

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

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026