Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorKorea Otsuka Pharmaceutical Co., Ltd.

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)

Treatment groups

222 Participants
are divided into 1 treatment group

Locations

This trial has no locations