[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508891":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":31,"interventions":31,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":209,"collaborators":31,"id":211,"slug":212,"hasResults":213,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":213,"sex":218,"minAge":219,"maxAge":31,"enrollmentInfo":220,"targetDuration":223,"studyType":224,"phases":31,"briefSummary":225,"conditions":226,"keywords":31,"overallStatus":54,"whyStopped":31,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Culture conversion rate","Conversion from positive cultures at baseline to negative cultures after 6 months of antimycobacterial treatment, defined by three or more negative sputum cultures sampled a month apart or one negative culture from a bronchial lavage.","6 months",[14,17,19,22,25,28],{"measure":15,"description":16,"timeFrame":12},"Change in mycobacterial load compared to baseline","Change in acid fast bacilli (AFB) smear determined by auramine staining",{"measure":15,"description":18,"timeFrame":12},"Change in time-to-positivity of positive cultures",{"measure":20,"description":21,"timeFrame":12},"Change in symptoms compared to baseline","Change in symptoms as judged by the treating physician",{"measure":23,"description":24,"timeFrame":12},"Adverse drug reactions to antimycobacterial treatment","Adverse drug reactions and the (assumed) causative antimycobacterial drug",{"measure":26,"description":27,"timeFrame":12},"Antimycobacterial treatment adjustments","Any change in the antimycobacterial treatment including the reason",{"measure":29,"description":30,"timeFrame":12},"Other treatment adjustments","Changes in concomitant medication, supportive care measures or a surgical intervention",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","PROSPECTIVE","Mycobacterium avium complex (MAC) is the most frequent causative species that results in nontuberculous mycobacterial pulmonary disease (NTM-PD). Current treatment outcomes for MAC-PD are unsatisfactory with sputum culture conversion rates between 50-70%.The high prevalence of drug toxicity and low adherence to guideline-based treatment (GBT) are key reasons for the limited treatment success. Hence, there is an unmet need for prospective data on effectiveness of, adherence and adjustments to MAC-PD treatment regimens. By collaborating with NTM-NET and ESGMYC affiliated medical centers, we enable systematic, prospective data collection of an international MAC-PD cohort.","Patients with Mycobacterium avium complex pulmonary disease that (MAC-PD) requires guideline-based three-drug antimycobacterial therapy. MAC is the most common causative species of pulmonary NTM infections.",[38],{"name":39,"affiliation":5,"role":40},"Jakko van Ingen, MSc, PhD","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Arthur Lemson, MSc","CONTACT","+31634265743","arthur.lemson@radboudumc.nl",{"name":48,"role":44,"phone":49,"phoneExt":31,"email":50},"Wouter Hoefsloot, MSc, PhD","+31611072569","wouter.hoefsloot@radboudumc.nl",[52,69,84,100,113,128,140,153,166,181,194],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Oregon Science and Health University","RECRUITING","Portland","Oregon","97239","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-122.67621,45.52345,{"lat":64,"lon":63},[67],{"name":68,"role":44,"phone":31,"phoneExt":31,"email":31},"Kevin Winthrop, MD, MPH",{"facility":70,"status":54,"city":71,"state":31,"zip":31,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"UZ Leuven","Leuven","Belgium","BE",{"type":61,"coordinates":75},[76,77],4.70093,50.87959,{"lat":77,"lon":76},[80],{"name":81,"role":44,"phone":82,"phoneExt":31,"email":83},"Natalie Lorent, MD, PhD","+32 16 33 22 11","natalie.lorent@uzleuven.be",{"facility":85,"status":54,"city":86,"state":87,"zip":31,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Calgary","Calgary","Alberta","Canada","CA",{"type":61,"coordinates":91},[92,93],-114.08529,51.05011,{"lat":93,"lon":92},[96],{"name":97,"role":44,"phone":98,"phoneExt":31,"email":99},"Christina Thornton, MD, PhD, FRCPC","+1 403-220-5110","Christina.Thornton@albertahealthservices.ca",{"facility":101,"status":54,"city":102,"state":31,"zip":31,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"University Hospital Center Zagreb","Zagreb","Croatia","HR",{"type":61,"coordinates":106},[107,108],15.97798,45.81444,{"lat":108,"lon":107},[111],{"name":112,"role":44,"phone":31,"phoneExt":31,"email":31},"Mateja Janković Makek, MD, PhD",{"facility":114,"status":54,"city":115,"state":31,"zip":31,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Aarhus University Hospital","Aarhus","Denmark","DK",{"type":61,"coordinates":119},[120,121],10.21076,56.15674,{"lat":121,"lon":120},[124],{"name":125,"role":44,"phone":126,"phoneExt":31,"email":127},"Andreas Fløe Hvass, MD, PhD","+45 70 11 31 31","andrniel@rm.dk",{"facility":129,"status":54,"city":130,"state":31,"zip":31,"country":116,"countryCode":117,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Rasmus Rude Laub","Hellerup",{"type":61,"coordinates":132},[133,134],12.57093,55.73204,{"lat":134,"lon":133},[137],{"name":31,"role":44,"phone":138,"phoneExt":31,"email":139},"+45 38 67 38 67","rasmus.rude.laub@regionh.dk",{"facility":141,"status":54,"city":142,"state":31,"zip":31,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"University Hospital Frankfurt","Frankfurt","Germany","DE",{"type":61,"coordinates":146},[147,148],10.53333,49.68333,{"lat":148,"lon":147},[151],{"name":152,"role":44,"phone":31,"phoneExt":31,"email":31},"Nils Wetzstein",{"facility":154,"status":54,"city":155,"state":31,"zip":31,"country":156,"countryCode":157,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Fukujuji Hospital","Tokyo","Japan","JP",{"type":61,"coordinates":159},[160,161],139.69171,35.6895,{"lat":161,"lon":160},[164],{"name":165,"role":44,"phone":31,"phoneExt":31,"email":31},"Masashi Ito, MD, PhD",{"facility":5,"status":54,"city":167,"state":31,"zip":168,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Nijmegen","6511LK","Netherlands","NL",{"type":61,"coordinates":172},[173,174],5.85278,51.8425,{"lat":174,"lon":173},[177,179],{"name":178,"role":44,"phone":45,"phoneExt":31,"email":46},"Arthur Lemson, MD",{"name":180,"role":44,"phone":49,"phoneExt":31,"email":50},"Wouter Hoefsloot, MD, PhD",{"facility":182,"status":54,"city":183,"state":31,"zip":31,"country":184,"countryCode":31,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Seoul National University Hospital","Seoul","South Korea",{"type":61,"coordinates":186},[187,188],126.9784,37.566,{"lat":188,"lon":187},[191],{"name":192,"role":44,"phone":31,"phoneExt":31,"email":193},"Nakwon Kwak","n.kwak@snu.ac.kr",{"facility":195,"status":54,"city":196,"state":31,"zip":31,"country":197,"countryCode":198,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Hospital Clínic de Barcelona","Barcelona","Spain","ES",{"type":61,"coordinates":200},[201,202],2.15899,41.38879,{"lat":202,"lon":201},[205],{"name":206,"role":44,"phone":207,"phoneExt":31,"email":208},"Julian Gonzalez-Martin, MD, PhD","+34 932 27 54 00","GONZALEZ@clinic.cat",{"type":210,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100508891","a-prospective-multicenter-single-arm-mac-pd-cohort-a-ntm-net-and-esgmyc-collaborative-study-100508891",false,"NCT05906316","A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study","MAC-PD cohort","Inclusion Criteria:\n\n* Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator\n* The participant has a known or suspected, current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient\n* HIV-infection;\n* Cystic fibrosis;\n* \\>1 month antibiotic treatment for current MAC infection;\n* \\\u003C 6 months between previous antimycobacterial NTM-PD treatment and antimycobacterial treatment for current MAC-PD\n* Disseminated MAC infection;\n* Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment;\n* Active pulmonary malignancy (primary or metastatic) or any other malignancy requiring chemotherapy or radiotherapy within 6 months before screening or anticipated during the study period;","ALL","18 Years",{"count":221,"type":222},100,"ESTIMATED","6 Months","OBSERVATIONAL","To gain insight in the effectiveness of, adherence and adjustments to guideline-based three-drug antimycobacterial therapy in patients with Mycobacterium avium complex pulmonary disease (MAC-PD) during the first 6 months of treatment.",[227],"Mycobacterium Avium Complex Pulmonary Disease","2026-09-10",{"date":230,"type":231},"2026-09-15","ACTUAL",{"date":233,"type":231},"2023-07-01",{"date":235,"type":222},"2027-09-01",{"name":5,"class":6},11]