About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- No intervention (observational study)