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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDR-END regimen treatment group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention (observational study) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minyi Lee | Contact | +82-02-3287-9286 | minyi.lee@kr.otsuka.com |
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| 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 |
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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