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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 222
- 主要终点
- Treatment success rate at the end of treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MDR-END regimen treatment group
- Treatment Regimen
Delamanid 100 mg twice daily Linezolid 600 mg once daily for the first 2 months, 300 mg once daily afterward Levofloxacin (body weight ≤ 50 kg) 750 mg once daily (body weight > 50 kg) 1000 mg once daily Pyrazinamide (body weight < 50 kg) 1000 mg once daily (body weight 50 to 70 kg) 1500 mg once daily (body weight > 70 kg) 2000 mg once daily 2. Treatment period : 9 month (40 weeks) If the sputum test results show conversion within 3-6 months after the start of treatment, the overall treatment period is extended by 3 months for a total of 12 months (52 weeks).
干预措施: No intervention (observational study) (Drug)
结局指标
主要结局
Treatment success rate at the end of treatment
时间窗: At the end of treatment
"Cured" and "Treatment Completed" from the result of multidrug resistant pulmonary tuberculosis treatment are defined as treatment success, and the treatment outcomes of multidrug resistant pulmonary tuberculosis treatment are determined according to the 5th edition of the Korean Guidelines for Tuberculosis.
次要结局
- Treatment success rate at 12 months after the end of treatment (end of study)(At 12 months after the end of treatment (end of study))
- Recurrence rate after treatment success(During follow up period (12 months after the end of treatment))
- Treatment-emergent adverse events (TEAEs)(During the treatment period and up to one month after the end of treatment)
- TEAEs by severity(During the treatment period and up to one month after the end of treatment)
- Mortality and time to death(During the treatment period and up to one month after the end of treatment)
- TEAEs related to QT prolongation(During the treatment period and up to one month after the end of treatment)