[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567907":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":10,"id":28,"slug":10,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":10,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":10,"enrollmentInfo":36,"targetDuration":39,"studyType":40,"phases":10,"briefSummary":41,"conditions":42,"keywords":10,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":10},{"fullName":5,"class":6},"Korea Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MDR-END regimen treatment group",null,"1. Treatment Regimen\n\n   Delamanid 100 mg twice daily Linezolid 600 mg once daily for the first 2 months, 300 mg once daily afterward Levofloxacin (body weight ≤ 50 kg) 750 mg once daily (body weight \\> 50 kg) 1000 mg once daily Pyrazinamide (body weight \\\u003C 50 kg) 1000 mg once daily (body weight 50 to 70 kg) 1500 mg once daily (body weight \\> 70 kg) 2000 mg once daily\n2. Treatment period : 9 month (40 weeks) If the sputum test results show conversion within 3-6 months after the start of treatment, the overall treatment period is extended by 3 months for a total of 12 months (52 weeks).",[13],"Drug: No intervention (observational study)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Minyi Lee","CONTACT","+82-02-3287-9286","minyi.lee@kr.otsuka.com",{"type":27,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100567907",false,"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)","Inclusion Criteria:\n\n1. Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis\n2. 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\n\nExclusion Criteria:\n\n1. Patients with confirmed quinolone resistance\n2. Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide\n3. Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide\n4. Patients with or with a history of optic neuritis or peripheral neuritis\n5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n6. Pregnant or lactating women\n7. Women of childbearing potential who are unwilling to use appropriate contraception during the study treatment","ALL","19 Years",{"count":37,"type":38},222,"ESTIMATED","2 Years","OBSERVATIONAL","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.\n\nIt will be conducted as a non-interventional, prospective, single group, multicenter design.\n\nSubjects who are considered to meet the inclusion \u002Fexclusion 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.",[43],"Tuberculosis, Multidrug-Resistant","NOT_YET_RECRUITING","2024-11-03",{"date":47,"type":48},"2024-11-05","ACTUAL",{"date":50,"type":38},"2024-11-30",{"date":52,"type":38},"2028-12-31",{"name":5,"class":6}]