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Not yet recruiting NCT06674291

Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)

— Observational Tuberculosis, Multidrug-Resistant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention (observational study).
Who it may be relevant to
Registry conditions: Tuberculosis, Multidrug-Resistant. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen (Delamanid, Linezolid, Levofloxacin, Pyrazinamide) in Korean Patients with Fluoroquinolone-Sensitive Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) : a Non-interventional, Prospective Observational Study (MDR-END Registry)

Overview

This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting. It will be conducted as a non-interventional, prospective, single group, multicenter design. Subjects who are considered to meet the inclusion /exclusion criteria will receive MDR-END regimen for 9 months (or 12 months) during the treatment period according to the 5th edition of the Korean Guidelines for Tuberculosis, and will be followed-up for 12 months after the end of treatment.

Interventions

  • Drug No intervention (observational study)
    This is an observational registry conducted in the real world clinical setting and there is no intervention in this study. Treatment of MDR-END Regimen and the follow-up of subjects will be conducted in the clinical judgment of the investigator.

Primary outcome measures

  • Treatment success rate at the end of treatment [Time frame: At the end of treatment]
Secondary outcome measures (6)
  • Treatment success rate at 12 months after the end of treatment (end of study) [Time frame: At 12 months after the end of treatment (end of study)]
  • Recurrence rate after treatment success [Time frame: During follow up period (12 months after the end of treatment)]
  • Treatment-emergent adverse events (TEAEs) [Time frame: During the treatment period and up to one month after the end of treatment]
  • TEAEs by severity [Time frame: During the treatment period and up to one month after the end of treatment]
  • Mortality and time to death [Time frame: During the treatment period and up to one month after the end of treatment]
  • TEAEs related to QT prolongation [Time frame: During the treatment period and up to one month after the end of treatment]

Eligibility criteria

Inclusion criteria

  • Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis
  • Adults prescribed MDR-END regimen according to the Korean Guidelines for Tuberculosis after being informed of this study from the investigator and signing an informed consent form

Exclusion criteria

  • Patients with confirmed quinolone resistance
  • Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide
  • Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide
  • Patients with or with a history of optic neuritis or peripheral neuritis
  • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Pregnant or lactating women
  • Women of childbearing potential who are unwilling to use appropriate contraception during the study treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06674291 · 242-402-00031

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗