[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100303961":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":46,"centralContacts":51,"locations":58,"responsibleParty":104,"collaborators":56,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":56,"enrollmentInfo":115,"targetDuration":56,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":78,"whyStopped":56,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Centre Hospitalier Universitaire, Amiens","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Clarithromycin 1000 MG","ACTIVE_COMPARATOR","The patient will received a combination of 3 antibiotics :\n\n* Rifampicin (10mg\u002Fkg once daily)\n* Ethambutol (15 to 20 mg\u002Fkg once daily)\n* Clarithromycin (500 mg twice daily)",[13,14,15],"Drug: Clarithromycin 1000 MG","Drug: Rifampicin","Drug: Ethambutol",{"label":17,"type":18,"description":19,"interventionNames":20},"Azithromycin 250 MG","EXPERIMENTAL","The patient will received a combination of 3 antibiotics :\n\n* Rifampicin (10mg\u002Fkg once daily)\n* Ethambutol (15 to 20 mg\u002Fkg once daily)\n* Azithromycin (250 mg once daily)",[21,14,15],"Drug: Azithromycin 250 mg",[23,29,35,41],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Clarithromycin, Ethambutol and Rifampicin.",[9],[28],"ZECLAR",{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Azithromycin 250 mg","The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Azithromycin, Ethambutol and Rifampicin.",[17],[34],"ZITHROMAX",{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Rifampicin","The patient will be received for at least 12 months, a dailty antibiotic treatment who is a combination of Azithromycin or Clarithromycin (according to the randomisation), Ethambutol and Rifampicin.",[17,9],[40],"RIFADINE",{"type":24,"name":42,"description":37,"armGroupLabels":43,"otherNames":44},"Ethambutol",[17,9],[45],"DEXAMBUTOL",[47],{"name":48,"affiliation":49,"role":50},"Didier RENAUT","CHU Amiens-Picardie","STUDY_DIRECTOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Claire ANDREJAK, PhD","CONTACT","+33322087893",null,"andrejak.claire@chu-amiens.fr",[59,76,86],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"CHU Amiens Picardie","NOT_YET_RECRUITING","Amiens","Picardie","80054","France","FR",{"type":68,"coordinates":69},"Point",[70,71],2.3,49.9,{"lat":71,"lon":70},[74],{"name":53,"role":54,"phone":75,"phoneExt":56,"email":57},"+33322455960",{"facility":77,"status":78,"city":79,"state":56,"zip":80,"country":65,"countryCode":66,"cosmosGeoPoint":81,"geoPoint":85,"contacts":56},"CHU Angers","RECRUITING","Angers","49933",{"type":68,"coordinates":82},[83,84],-0.55202,47.47156,{"lat":84,"lon":83},{"facility":87,"status":78,"city":88,"state":56,"zip":89,"country":65,"countryCode":66,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Saint Joseph Hospital","Marseille","13000",{"type":68,"coordinates":91},[92,93],5.38107,43.29695,{"lat":93,"lon":92},[96,100],{"name":97,"role":54,"phone":98,"phoneExt":56,"email":99},"Audoly Cristina, PH","+334 91 80 67 05","caudoly@hopital-saint-joseph.fr",{"name":101,"role":54,"phone":102,"phoneExt":56,"email":103},"Bezirganyan Kristina","+334 91 80 65 00","kbezirganyan@hopital-saint-joseph.fr",{"type":105,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100303961","phase-3-clarithromycin-versus-azithromycin-in-the-treatment-of-mycobacterium-avium-complex-mac-lung-infections-100303961",false,"NCT03236987","CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections","CLAZI","Inclusion Criteria:\n\n* patients 18 years of age or older\n* having a positive Mycobacterium avium complex sample showing the ATS \u002F IDSA infection criteria and requiring treatment\n* ATS \u002F IDSA infection criteria combine clinico-radiological criteria, associated with microbiological criteria\n* the exclusion of any other diagnosis on the thoracic CT, fibroscopy and bacteriological samples\n\nExclusion Criteria:\n\n* Known hypersensitivity to one of the study molecules (rifampicin, ethambutol, azithromycin, clarithromycin)\n* Relapse of an MAC infection,\n* Strain resistant to macrolides, based on genotyping susceptibility testing (genotyping susceptibility testing must be done before inclusion)\n* Treatment that interacts with cytochrome p450 that can not be replaced by another therapeutic,\n* HIV serology 1 and 2,\n* Renal insufficiency with creatinine clearance less than 30 ml \u002F min,\n* Pregnancy and breast feeding,\n* Contra-indication to one of the antibiotics,\n* Impossibility to follow the protocol due in particular to drug addiction according to the investigator,\n* Limited life expectancy, less than 6 months,\n* Patient already participating in a clinical trial on a medical treatment or a therapeutic strategy for non-tuberculous mycobacteria.","ALL","18 Years",{"count":116,"type":117},424,"ESTIMATED","INTERVENTIONAL",[120],"PHASE3","MAC lung infections are a growing public health problem. The ATS \u002F IDSA 2007 guidelines for the treatment of these non-tuberculous mycobacterial infections recommend the use of a macrolide or azalide (clarithromycin or azithromycin), rifampicin or rifabutin and ethambutol.\n\nFor MAC disseminated infections, several studies have compared combinations containing clarithromycin or azithromycin and found no significant difference in efficacy. No randomized controlled trials have been performed for pulmonary infections to compare clarithromycin and azithromycin in terms of efficacy. Clarithromycin is often used as a first-line treatment in France, but its tolerance is often poor, particularly in terms of risk of hepatitis, metallic taste in the mouth, nausea or vomiting, and it interacts with many drugs via cytochrome p450 . In particular, it increases the toxicity of rifabutin, in particular in terms of uveitis. Azithromycin has fewer side effects especially less digestive toxicity and drug interactions than clarithromycin.\n\nThe hypothesis is therefore that the efficacy of azithromycin would be non-inferior in comparison with that of clarithromycin.",[123,124],"Lung Infection","MAC Lung Disease",[126,127,128,129],"Clarithromycin","Azithromycin","Efficacy","Safety","2025-11-17",{"date":132,"type":133},"2025-11-19","ACTUAL",{"date":135,"type":133},"2018-02-05",{"date":137,"type":117},"2029-02-05",{"name":5,"class":6},3]