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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)
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.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
November 30, 2024
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2028
Last Updated
November 5, 2024
222
ESTIMATED participants
No intervention (observational study)
DRUG
Lead Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
NCT02354014
NCT03828201
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03086486