Tuberculosis, Multidrug-Resistant
Conditions
Brief summary
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.
Interventions
DRUGNo 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.
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis 2. 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
Exclusion criteria
1. Patients with confirmed quinolone resistance 2. Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide 3. Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide 4. Patients with or with a history of optic neuritis or peripheral neuritis 5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 6. Pregnant or lactating women 7. Women of childbearing potential who are unwilling to use appropriate contraception during the study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success rate at the end of treatment | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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) |
| 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 |
| TEAEs by severity | During the treatment period and up to one month after the end of treatment |
Contacts
Primary ContactMinyi Lee
Outcome results
None listed