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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)

StatusNot Yet Recruiting
PhaseNot specified
Started2024-11-30
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT06674291
Lead Sponsor Korea Otsuka Pharmaceutical Co., Ltd.
Conditions Tuberculosis, Multidrug-Resistant
Enrollment 222 participants
Start Date 2024-11-30
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-05