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)

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Treatment success rate at the end of treatment [Срок оценки: At the end of treatment]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06674291 · 242-402-00031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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