[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608217":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":51,"locations":30,"responsibleParty":58,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":85,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":30},{"fullName":5,"class":6},"Wuhan Pulmonary Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"test group","EXPERIMENTAL","6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen\n\nInterventions:\n\nDrug: bedaquiline Drug: delamanid Drug: linezolid Drug: Levofloxacin",[13,14,15,16],"Drug: bedaquiline","Drug: Delamanid (DLM)","Drug: Linezolid (LZD)","Drug: Levofloxacin",{"label":18,"type":19,"description":20,"interventionNames":21},"Control group (Group A)","ACTIVE_COMPARATOR","Six months of bedaquiline, linezolid, levofloxacin, cycloserine, and clofazimine, followed by 12 months of levofloxacin, cycloserine, and clofazimine.",[13,14,15,16,22,23],"Drug: Cycloserine","Drug: Clofazimine",[25,31,35,39,43,47],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","bedaquiline","Administer 400 mg orally once daily for 2 weeks, followed by 200 mg orally three times a week for 22 weeks",[18,9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Delamanid (DLM)","Administer 100 mg orally, twice daily for 24 weeks.",[18,9],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Linezolid (LZD)","Administer 600 mg orally, once daily for 24 weeks.",[18,9],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"Levofloxacin","test group:Administer 800 mg orally, once daily for 24 weeks;control group:Administer 800 mg orally, once daily for 72 weeks",[18,9],{"type":26,"name":44,"description":45,"armGroupLabels":46,"otherNames":30},"Cycloserine","Administer 250mg orally, twice daily for 72 weeks.",[18],{"type":26,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"Clofazimine","Administer 100 mg orally, once daily for 72 weeks",[18],[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Shuang Wei, Doctor, director of hospital","CONTACT","+8602783602347","8618062087116","shuangwei@tjh.tjmu.edu.cn",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Yan Hu","Shuang Wei,Vice-President","100608217","6-months-of-bedaquilinebdq-delamaniddlm-linezolidlzd-and-levofloxacinlfx-in-rr-tb-patients-in-hubei-province-100608217",false,"NCT07198685","6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province","6 Months of Bedaquiline, Delamanid, Linezolid and Levoffoxacin in RR-TB Patients in Hubei Province","BDLL","Inclusion Criteria:\n\n* Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions will be included.\n* Aged between 18 and 65 years old.\n* Have never used bedaquiline, delamanid, linezolid, or levofloxacin in the past, or have used them for no more than 4 weeks.\n* Positive results of mycobacterial culture (either smear-positive or smear-negative) within the recent one month, and no effective anti-tuberculosis treatment received within this one-month period; or in the absence of recent sputum culture results, smear-positive sputum and no effective anti-tuberculosis treatment administered.\n* No history of respiratory failure or cardiac insufficiency, and no clinically significant arrhythmia manifestations on electrocardiogram.\n* During the treatment and follow - up periods, patients are required to take medications as per the research project requirements, complete treatment monitoring, and promptly report any adverse reactions to the attending physicians.\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Individuals with a history of optic neuropathy or peripheral neuropathy, whom the researchers believe may experience progression\u002Fworsening during the study or are not suitable for participation in this research.\n* Chronic active hepatitis, with positive results for three items: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B core antibody (anti - HBc), or HBV - DNA \\> 1000 CPs\u002FmL, accompanied by elevated ALT\u002FAST. Elevation of ALT or AST is ≥3 times the upper limit of the normal value, or elevation of total bilirubin and direct bilirubin is ≥2 times the upper limit of the normal value (if it is a temporary elevation, patients can be enrolled after recovery from treatment).\n* Severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 mL\u002Fmin).\n* Individuals who have participated in clinical trials of other unlisted new drugs within the past three months.\n* Known congenital QT interval prolongation, presence of any disease that can prolong the QT interval, or a QTc \\> 450 ms.\n* Pregnant women or women who may be pregnant.\n* Any cardiac diseases capable of inducing arrhythmia, such as severe hypertension (poorly controlled blood pressure), left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure accompanied by a reduced left ventricular ejection fraction.\n* A history of known, untreated, and persistent hypothyroidism. Combined with hematogenous disseminated tuberculosis and central nervous system tuberculosis.\n* A history of allergy or a known allergy to any investigational medicinal product or related substances.\n* HIV-positive.","ALL","18 Years","65 Years",{"count":74,"type":75},52,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study aims to compare the efficacy and safety of a 6-month all-oral regimen including Bedaquiline (BDQ,B), Delamanid (DLM,D), Linezolid (LZD, L), and Levofloxacin (LFX,L) to the the standard long - course treatment regimen within the Chinese population. The main questions it aims to answer are:\n\nIs the efficacy of short regimen non-inferior to standard regimen? Is the short regimen safe enough to replace the standard regimen?\n\nParticipants will:\n\nBe given with either short or standard regimen for RR-TB treatment Be asked to complete the scheduled visit as planned.",[81,82],"Treat to Target","Treatment Duration",[68,84],"RR\u002FMDR-TB","NOT_YET_RECRUITING","2025-09-21",{"date":88,"type":89},"2025-09-30","ACTUAL",{"date":88,"type":75},{"date":92,"type":75},"2028-09-30",{"name":5,"class":6}]