Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06674291 | NOT YET RECRUITING | Tuberculosis, Multidrug-Resistant

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)
Sponsor:

Korea Otsuka Pharmaceutical Co., Ltd.

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.

Condition or disease

Tuberculosis, Multidrug-Resistant

Intervention/treatment

No intervention (observational study)

Study Type : OBSERVATIONAL
Estimated Enrollment : 222 participants
Official Title : Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen (Delamanid, Linezolid, Levofloxacin, Pyrazinamide) in Korean Patients with Fluoroquinolone-Sensitive Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) : a Non-interventional, Prospective Observational Study (MDR-END Registry)
Actual Study Start Date : 2024-11-30
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
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)

Location Details

NCT06674291

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found