NCT06674291

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)

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 222 (estimated)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis, Multidrug-Resistant

Interventions

Type	Name	Description
DRUG	No 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.

Timeline

• Start date: 2024-11-30
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2024-11-05
• Last updated: 2024-11-05