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.
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
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
222 adult men and women with fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis will be enrolled in this study. To determine the sample size of this study, the treatment success rate of the study group in the MDR-END trial treated with Delamanid, Linezolid, Levofloxacin, and Pyrazinamide to shorten the treatment duration of multidrug resistant tuberculosis in patients with fluoroquinolone-sensitive multidrug resistant tuberculosis was assumed to be the expected effectiveness rate. The treatment success rate of the study group in the MDR-END trial was 84.72% according to the 5th edition of the Korean Guidelines for Tuberculosis, and the number of subjects required was 222 subjects calculated with a 95% confidence interval, 5% tolerance and 10% dropout rate.
Cohort
Prospective
No intervention (observational study)
DrugThis 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.
Treatment success rate 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.
Treatment success rate at 12 months after the end of treatment (end of study)
Recurrence rate after treatment success
Treatment-emergent adverse events (TEAEs)
TEAEs by severity
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