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.
Study Type
OBSERVATIONAL
Enrollment
222
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.
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.
Time frame: At the end of treatment
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
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