[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609375":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":30,"studyPopulation":30,"armGroups":50,"interventions":63,"overallOfficials":90,"centralContacts":95,"locations":101,"responsibleParty":156,"collaborators":160,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":30,"eligibilityCriteria":178,"healthyVolunteers":175,"sex":179,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":30,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":104,"whyStopped":30,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Capital Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":33},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"culture conversion","2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture\u002FNGS.","end of month 6",{"measure":14,"description":15,"timeFrame":12},"CT lesion absorption","\\>30% decrease in lesion size or number of nodules measured on CT",{"measure":17,"description":18,"timeFrame":12},"QOL-B+NTM module","Improvement greater than MID in at least 7 out of 12 domains in QOL-B with NTM-module (must include respiratory symptoms and NTM-PD symptoms)",[20,22,25,28,31],{"measure":10,"description":11,"timeFrame":21},"up to month 12",{"measure":23,"description":15,"timeFrame":24},"CT lesion status","end of month 3, 6, and 12 (for standard regimen)\u002Fend of month 3 and 6 (for shortened regimen)",{"measure":26,"description":27,"timeFrame":21},"Questionnaire: Quality of life-bronchiectasis (QOL-B) and NTM module","Improvement greater than minimal importance difference in at least 7 out of 12 domains in QOL-B with NTM module (must include respiratory symptoms and NTM-PD symptoms)",{"measure":29,"description":30,"timeFrame":21},"SGRQ",null,{"measure":32,"description":30,"timeFrame":21},"time to positivity of mycobacterium culture",[34,37,41],{"measure":35,"description":36,"timeFrame":21},"Number of participants with adverse events","Adverse events related to study intervention (short-term regimen and standard regimen) are reported by participants.",{"measure":38,"description":39,"timeFrame":40},"MAC strain drug-sensitivity","Phenotypic drug sensitivity will be evaluated with microdilution method for macrolides, amikacin, rifampicin, and ethanmbutol","end of month 6 (for shortened regimen)\u002Fend of month 12 (for standard regimen)",{"measure":42,"description":43,"timeFrame":21},"Number of participants with treatment-related abnormal laboratory tests results","Laboratory tests include complete blood count, liver function and kidney function. Abnormalities will be recorded and discussed to determine the causality between treatment and laboratory findings.",{"allocation":45,"interventionModel":46,"interventionModelDescription":30,"primaryPurpose":47,"observationalModel":30,"timePerspective":30,"maskingInfo":48},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":49,"maskingDescription":30,"whoMasked":30},"NONE",[51,59],{"label":52,"type":53,"description":30,"interventionNames":54},"Contezolid shortened regimen","EXPERIMENTAL",[55,56,57,58],"Drug: Contezolid","Drug: Azithromycin","Drug: Ethambutol (E)","Drug: Rifampicin (R)",{"label":60,"type":61,"description":30,"interventionNames":62},"Standard regimen","ACTIVE_COMPARATOR",[56,57,58],[64,69,73,76,80,83,87],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":30},"DRUG","Contezolid","contezolid 800mg po q12h\\*6m",[52],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":30},"Azithromycin","azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\\*6m",[52],{"type":65,"name":70,"description":74,"armGroupLabels":75,"otherNames":30},"azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\\*12m",[60],{"type":65,"name":77,"description":78,"armGroupLabels":79,"otherNames":30},"Ethambutol (E)","ethambutol 25mg\u002Fkg po tiw\\*6m",[52],{"type":65,"name":77,"description":81,"armGroupLabels":82,"otherNames":30},"ethambutol 25mg\u002Fkg po tiw\\*12m",[60],{"type":65,"name":84,"description":85,"armGroupLabels":86,"otherNames":30},"Rifampicin (R)","rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\\*6m",[52],{"type":65,"name":84,"description":88,"armGroupLabels":89,"otherNames":30},"rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\\*12m",[60],[91],{"name":92,"affiliation":93,"role":94},"Xiaojin Cui, M.D.","China-Japan Friendship Hospital","PRINCIPAL_INVESTIGATOR",[96],{"name":97,"role":98,"phone":99,"phoneExt":30,"email":100},"Siwei Gu, M.D.","CONTACT","+861084205566","orbitline2@gmail.com",[102,115,124,128,138,147],{"facility":103,"status":104,"city":105,"state":106,"zip":30,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":30},"Anhui Chest Hospital","RECRUITING","Hefei","Anhui","China","CN",{"type":110,"coordinates":111},"Point",[112,113],117.28083,31.86389,{"lat":113,"lon":112},{"facility":116,"status":104,"city":117,"state":118,"zip":30,"country":107,"countryCode":108,"cosmosGeoPoint":119,"geoPoint":123,"contacts":30},"Beijing Chest Hospital, Capital Medical University","Beijing","Beijing Municipality",{"type":110,"coordinates":120},[121,122],116.39723,39.9075,{"lat":122,"lon":121},{"facility":93,"status":104,"city":117,"state":118,"zip":30,"country":107,"countryCode":108,"cosmosGeoPoint":125,"geoPoint":127,"contacts":30},{"type":110,"coordinates":126},[121,122],{"lat":122,"lon":121},{"facility":129,"status":130,"city":131,"state":132,"zip":30,"country":107,"countryCode":108,"cosmosGeoPoint":133,"geoPoint":137,"contacts":30},"Guangzhou Chest Hospital","NOT_YET_RECRUITING","Guangzhou","Guangdong",{"type":110,"coordinates":134},[135,136],113.25,23.11667,{"lat":136,"lon":135},{"facility":139,"status":104,"city":140,"state":141,"zip":30,"country":107,"countryCode":108,"cosmosGeoPoint":142,"geoPoint":146,"contacts":30},"Jiangxi Chest Hospital","Nanchang","Jiangxi",{"type":110,"coordinates":143},[144,145],115.85306,28.68396,{"lat":145,"lon":144},{"facility":148,"status":130,"city":149,"state":150,"zip":30,"country":107,"countryCode":108,"cosmosGeoPoint":151,"geoPoint":155,"contacts":30},"Shanghai Pulmonary Hospital","Shanghai","Shanghai Municipality",{"type":110,"coordinates":152},[153,154],121.45806,31.22222,{"lat":154,"lon":153},{"type":157,"investigatorFullName":158,"investigatorTitle":159,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Bin Cao","Professor",[161,164,166,168,169,171],{"name":162,"class":163},"MicuRx","INDUSTRY",{"name":165,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China",{"name":167,"class":6},"Beijing Chest Hospital",{"name":103,"class":6},{"name":139,"class":170},"UNKNOWN",{"name":172,"class":6},"Guangzhou Chest Hospital.","100609375","phase-4-short-term-antibiotic-therapy-in-mycobacterium-avium-complex-pulmonary-disease-100609375",false,"NCT07213765","Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease","Inclusion Criteria:\n\n1. Patients voluntarily participate in this study and sign the Informed Consent Form.\n2. Age ≥ 18 years and ≤75 years; gender unrestricted.\n3. Confirmed diagnosis of MAC pulmonary disease per ATS\u002FIDSA 2020 guidelines or Chinese Guidelines for Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases (2020 edition), with imaging features consistent with nodular bronchiectatic type.\n4. No prior anti-MAC treatment within the 3 months preceding screening.\n5. For premenopausal women of childbearing potential who are not surgically sterile:\n\n   Must use a medically accepted contraceptive method (e.g., intrauterine device, hormonal contraception, or condom) during the study period and for 3 months following the last dose of investigational treatment.\n\n   Serum or urine human chorionic gonadotropin (hCG) test must be negative within 72 hours prior to enrollment.\n\n   Must not be breastfeeding. Male patients with partners of childbearing potential must use effective contraception during the study period and for 3 months after the last dose.\n6. Organ function criteria met within one week prior to enrollment:\n\ni. Hemoglobin ≥60 g\u002FL; ii. Neutrophil count ≥0.5 × 10⁹\u002FL; iii. Platelet count ≥60 × 10⁹\u002FL; iv. Serum total bilirubin ≤3 × upper limit of normal (ULN); v. Aspartate aminotransferase (AST) ≤3 × ULN; vi. Alanine aminotransferase (ALT) ≤3 × ULN; vii. Serum creatinine \\\u003C2 × ULN OR creatinine clearance ≥60 mL\u002Fmin; viii. Blood urea nitrogen (BUN) ≤200 mg\u002FL; ix. Urinalysis: Proteinuria \\\u003C++; if proteinuria is +, 24-hour total protein must be \\\u003C500 mg.\n\nx. Fasting blood glucose within normal range OR stable glycemic control in diabetic patients.\n\nxi. Cardiac function: No myocardial infarction in the preceding 6 months; No unstable angina or severe arrhythmias; New York Heart Association (NYHA) functional class \\>II.\n\nExclusion Criteria:\n\n1. History of allergy to any study drug in the treatment regimen.\n2. Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).\n3. Presence of congenital\u002Facquired immunodeficiency disorders, active pulmonary malignancy (primary or metastatic), or other malignancies requiring chemotherapy\u002Fradiation therapy during the screening or study period.\n4. History of solid organ transplantation.\n5. Currently undergoing dialysis.\n6. Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence, uncontrolled and significant pleural effusion or pericardial effusion.\n7. Unstable systemic comorbidities including:\n\n   Hypertensive crisis; Unstable angina; Congestive heart failure (NYHA Class III\u002FIV); Myocardial infarction within the preceding 6 months; Severe psychiatric disorders requiring medication (e.g., schizophrenia, bipolar disorder); Severe hepatic or renal dysfunction (e.g., Child-Pugh Class C cirrhosis, eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²); Neurodegenerative diseases (e.g., Alzheimer's disease).\n8. Poor gastrointestinal function or malabsorption syndrome.\n9. Receipt of other investigational drugs within 4 weeks prior to the first study drug administration.\n10. Concurrent participation in another interventional clinical trial, unless it is an observational\u002Fnoninterventional study OR follow-up phase of a completed intervention trial.\n11. Any physical examination findings or clinical tests deemed by the investigator as likely to:\n\nInterfere with study results; Increase risks of complications during treatment.","ALL","18 Years","75 Years",{"count":183,"type":184},188,"ESTIMATED","INTERVENTIONAL",[187],"PHASE4","The goal of this clinical trial is to learn if adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage of contezolid. The main questions it aims to answer are:\n\nDoes adding contezolid to standard regimen decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease? What medical problems do participants have when taking contezolid for an extended length? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease?\n\nParticipants will:\n\nTake contezolid and standard regimen (azithromycin, ethambutol, and rifampicin) for 6 months, contezolid is administered every day while other drugs are taken three times a week OR take standard regimen three times a week for 12 months.\n\nVisit the clinic once every 1 month for checkups and tests.",[190],"Mycobacterium Avium Complex Pulmonary Disease",[190,192,193],"non-tuberculous mycobacterium","contezolid","2025-10-02",{"date":196,"type":197},"2025-10-09","ACTUAL",{"date":199,"type":197},"2025-07-24",{"date":201,"type":184},"2028-12-31",{"name":158,"class":6},6]