[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100386376":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":50,"centralContacts":106,"locations":116,"responsibleParty":510,"collaborators":514,"id":540,"slug":541,"hasResults":542,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":542,"sex":548,"minAge":50,"maxAge":50,"enrollmentInfo":549,"targetDuration":50,"studyType":552,"phases":553,"briefSummary":556,"conditions":557,"keywords":559,"overallStatus":119,"whyStopped":50,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":577},{"fullName":5,"class":6},"The University of Queensland","OTHER",[8,21,26,30,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive Therapy A","ACTIVE_COMPARATOR","Following Randomisation 1, Participants will receive intensive drug therapy in the form of IV amikacin, IV tigecycline, IV cefoxitin\u002Fimipenem + oral azithromycin AND clofazimine.",[13,14,15,16,17,18,19,20],"Drug: Amikacin","Drug: Tigecycline","Drug: Imipenem","Drug: Cefoxitin","Drug: Azithromycin","Drug: Clarithromycin","Drug: Clofazimine","Drug: Ethambutol",{"label":22,"type":23,"description":24,"interventionNames":25},"Intensive Therapy B","EXPERIMENTAL","Following Randomisation 1, Participants will receive inhaled amikacin (IA), IV tigecycline, IV cefoxitin\u002Fimipenem + oral azithromycin\u002Foral clarithromycin AND clofazimine.",[14,15,16,17,18,19,20,13],{"label":27,"type":23,"description":28,"interventionNames":29},"Intensive Therapy C","Following Randomisation 1, Participants will receive intensive drug therapy in the form of IV amikacin, IV tigecycline, IV cefoxitin\u002Fimipenem + oral azithromycin\u002Foral clarithromycin.",[13,14,15,16,17,18,20],{"label":31,"type":10,"description":32,"interventionNames":33},"Consolidation A","Oral clofazimine + oral azithromycin\u002Foral clarithromycin in combination with one to three of the following oral antibiotics: oral linezolid, oral co-trimoxazole, oral doxycycline, oral moxifloxacin, oral bedaquiline (adults only), oral rifabutin.",[17,18,19,20,34,35,36,37,38,39],"Drug: Linezolid","Drug: co-trimoxazole","Drug: Doxycycline","Drug: Moxifloxacin","Drug: Bedaquiline","Drug: Rifabutin",{"label":41,"type":23,"description":42,"interventionNames":43},"Consolidation B","Inhaled amikacin (IA), oral clofazimine + oral azithromycin\u002Foral clarithromycin in combination with one to three of the following oral antibiotics: oral linezolid, oral co-trimoxazole, oral doxycycline, oral moxifloxacin, oral bedaquiline (adults only), oral rifabutin.",[17,18,19,20,13,34,35,36,37,38,39],[45,51,55,59,63,67,71,75,79,82,86,90,94,98,102],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Amikacin","Adults: Intravenous amikacin 5mg\u002Fkg once daily or 7.5mg\u002Fkg twice daily or 20-25 mg\u002Fkg thrice weekly. Children:Intravenous amikacin 15-30 mg\u002Fkg once daily, maximum dose 1500mg",[9,27],null,{"type":46,"name":52,"description":53,"armGroupLabels":54,"otherNames":50},"Tigecycline","Adults: Intravenous Tigecycline 25 mg increasing by 5 mg every two doses until either maximum dose reached (50mg) or until patient is unable to tolerate twice daily. Children (≥8 years of age) intravenous tigecycline: Day 1- 0.6mg\u002Fkg twice daily to a maximum of 25mg. Day 2- 0.6mg\u002Fkg (maximum 25mg) in the morning, 1.2 mg\u002Fkg (maximum 50mg) at night. Day 3- 1.2mg\u002Fkg (maximum 50 mg) twice daily",[9,22,27],{"type":46,"name":56,"description":57,"armGroupLabels":58,"otherNames":50},"Imipenem","Adults: Intravenous Imipenem (≥50kg) 500mg twice daily (\\\u003C50kg) 15 mg\u002Fkg twice daily. Children: intravenous imipenem Day 1- 2- 25mg\u002Fkg (maximum 1g) twice daily. DAY 3- 25mg\u002Fkg (maximum 1g) four times daily (drop to 3 if not tolerated).",[9,22,27],{"type":46,"name":60,"description":61,"armGroupLabels":62,"otherNames":50},"Cefoxitin","Adults: If imipenem is poorly tolerated intravenous cefoxitin 200 mg\u002Fkg thrice daily. Children: if imipenem is poorly tolerated intravenous cefoxitin 50mg\u002Fkg (maximum 4g) four times daily.",[9,22,27],{"type":46,"name":64,"description":65,"armGroupLabels":66,"otherNames":50},"Azithromycin","Adults: Oral azithromycin 500mg (≥40kg) once daily, (\\\u003C40kg) 250mg once daily.During consolidaiton: 500mg (≥40kg) thrice weekly, (\\\u003C40kg) 250mg thrice weekly.\n\nChildren: Oral azithromycin:10mg\u002Fkg (maximum 500mg) once daily. During consolidation 10mg\u002Fkg once daily maximum 500mg.",[31,41,9,22,27],{"type":46,"name":68,"description":69,"armGroupLabels":70,"otherNames":50},"Clarithromycin","Adult: If azithromycin is poorly tolerated use oral clarithromycin 500mg twice daily.Children: If azithromycin is poorly tolerated use oral clarithromycin. In children 1 month old- 11years of age the following dosing applies: \\\u003C8kg: 7.5mg\u002Fkg twice daily, maximum dose 62.5mg, 8-11kg: 62.5mg twice daily, maximum dose 62.5mg, 12-19 kg: 125mg twice daily, maximum dose 125mg, 20-29 kg: 187.5mg twice daily, maximum dose 187.5mg, 30-40 kg: 250mg twice daily, maximum dose 250mg, Children 12-18 years of age: 500 mg twice daily",[31,41,9,22,27],{"type":46,"name":72,"description":73,"armGroupLabels":74,"otherNames":50},"Clofazimine","Adult: Oral clofazimine 100mg once daily. Children: Oral clofazimine: 3-5mg\u002Fkg once daily. Maximum dose of 50mg once daily if \\\u003C40kg or 100mg if ≥40kg once daily.",[31,41,9,22],{"type":46,"name":76,"description":77,"armGroupLabels":78,"otherNames":50},"Ethambutol","Adults: with confirmed mixed NTM infections (slow growers + MABS) oral ethambutol can be added at either 15 mg\u002Fkg once daily or 25mg\u002Fkg thrice weekly. Children with confirmed mixed NTM infections (slow growers + MABS) oral ethambutol can be added at 20 mg\u002Fkg once daily.",[31,41,9,22,27],{"type":46,"name":47,"description":80,"armGroupLabels":81,"otherNames":50},"adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily",[41,22],{"type":46,"name":83,"description":84,"armGroupLabels":85,"otherNames":50},"Linezolid","Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral linezolid 600mg once daily.\n\nChildren: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Age 1 week - 9 years 10mg\u002Fkg twice daily maximum dose of 300mg. Age 10-12 years 10mg\u002Fkg twice daily maximum dose of 600mg. \\>12 years 600mg once daily.",[31,41],{"type":46,"name":87,"description":88,"armGroupLabels":89,"otherNames":50},"co-trimoxazole","Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral Co-trimoxazole (TMP-SMX) 160\u002F800mg twice daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral co-trimoxazole 5mg TMP\u002Fkg maximum dose of 160mg TMP\u002F 800mg SMX twice daily.",[31,41],{"type":46,"name":91,"description":92,"armGroupLabels":93,"otherNames":50},"Doxycycline","Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline 100mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline (ages ≥ 8 years) 2mg\u002Fkg once daily maximum dose 100mg.",[31,41],{"type":46,"name":95,"description":96,"armGroupLabels":97,"otherNames":50},"Moxifloxacin","Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 400mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 10-15mg\u002Fkg once daily, maximum dose 400mg",[31,41],{"type":46,"name":99,"description":100,"armGroupLabels":101,"otherNames":50},"Bedaquiline","Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral bedaquiline (18-64 years of age) 400mg once daily for the first two weeks followed by 400mg thrice weekly for 22 weeks (maximum duration of 6 months).",[31,41],{"type":46,"name":103,"description":104,"armGroupLabels":105,"otherNames":50},"Rifabutin","Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin: 5mg\u002Fkg once daily, maximum 300-450mg. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin 5mg\u002Fkg once daily",[31,41],[107,112],{"name":108,"role":109,"phone":110,"phoneExt":50,"email":111},"Claire Wainwright, MD","CONTACT","+61730697322","claire.wainwright@health.qld.gov.au",{"name":113,"role":109,"phone":114,"phoneExt":50,"email":115},"Kara Brady, MPharm","+61730697618","FORMaTtrial@health.qld.gov.au",[117,130,144,152,161,169,179,187,195,204,212,220,228,236,244,252,257,265,273,278,286,294,299,309,314,322,327,335,343,346,356,366,376,384,394,402,407,415,423,431,436,444,452,460,468,476,481,486,494,502],{"facility":118,"status":119,"city":120,"state":121,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":50},"St George Hospital","RECRUITING","Kogarah","New South Wales","Australia","AU",{"type":125,"coordinates":126},"Point",[127,128],151.13564,-33.9681,{"lat":128,"lon":127},{"facility":131,"status":119,"city":132,"state":133,"zip":134,"country":122,"countryCode":123,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Queensland Children's Hospital","South Brisbane","Queensland","4101",{"type":125,"coordinates":136},[137,138],153.02049,-27.48034,{"lat":138,"lon":137},[141],{"name":142,"role":109,"phone":143,"phoneExt":50,"email":115},"Tiffany Jong","+61730697620",{"facility":145,"status":119,"city":146,"state":133,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":147,"geoPoint":151,"contacts":50},"Princess Alexandra Hospital","Woolloongabba",{"type":125,"coordinates":148},[149,150],153.03655,-27.48855,{"lat":150,"lon":149},{"facility":153,"status":119,"city":154,"state":155,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":156,"geoPoint":160,"contacts":50},"Austin Hospital","Heidelberg","Victoria",{"type":125,"coordinates":157},[158,159],145.06667,-37.75,{"lat":159,"lon":158},{"facility":162,"status":119,"city":163,"state":155,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":164,"geoPoint":168,"contacts":50},"Royal Melbourne Hospital","Parkville",{"type":125,"coordinates":165},[166,167],144.95,-37.78333,{"lat":167,"lon":166},{"facility":170,"status":119,"city":171,"state":172,"zip":173,"country":122,"countryCode":123,"cosmosGeoPoint":174,"geoPoint":178,"contacts":50},"Royal Perth Hospital","Perth","Western Australia","6000",{"type":125,"coordinates":175},[176,177],115.8614,-31.95224,{"lat":177,"lon":176},{"facility":180,"status":119,"city":181,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":182,"geoPoint":186,"contacts":50},"Royal Adelaide Hospital","Adelaide",{"type":125,"coordinates":183},[184,185],138.59863,-34.92866,{"lat":185,"lon":184},{"facility":188,"status":119,"city":189,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":190,"geoPoint":194,"contacts":50},"Sunshine Coast University Hospital","Birtinya",{"type":125,"coordinates":191},[192,193],153.11913,-26.74322,{"lat":193,"lon":192},{"facility":196,"status":197,"city":198,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":199,"geoPoint":203,"contacts":50},"Royal Prince Alfred Hospital","NOT_YET_RECRUITING","Camperdown",{"type":125,"coordinates":200},[201,202],151.17642,-33.88965,{"lat":202,"lon":201},{"facility":205,"status":119,"city":206,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":207,"geoPoint":211,"contacts":50},"The Prince Charles Hospital","Chermside",{"type":125,"coordinates":208},[209,210],153.03062,-27.38472,{"lat":210,"lon":209},{"facility":213,"status":119,"city":214,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":215,"geoPoint":219,"contacts":50},"Gold Coast University Hospital","Gold Coast",{"type":125,"coordinates":216},[217,218],153.43088,-28.00029,{"lat":218,"lon":217},{"facility":221,"status":119,"city":222,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":223,"geoPoint":227,"contacts":50},"Greenslopes Private Hospital,","Greenslopes",{"type":125,"coordinates":224},[225,226],153.04951,-27.50815,{"lat":226,"lon":225},{"facility":229,"status":119,"city":230,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":231,"geoPoint":235,"contacts":50},"Sir Charles Gairdiner Hospital","Nedlands",{"type":125,"coordinates":232},[233,234],115.8073,-31.98184,{"lat":234,"lon":233},{"facility":237,"status":197,"city":238,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":239,"geoPoint":243,"contacts":50},"John Hunter Hospital","New Lambton",{"type":125,"coordinates":240},[241,242],151.7085,-32.92838,{"lat":242,"lon":241},{"facility":245,"status":197,"city":246,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":247,"geoPoint":251,"contacts":50},"John Hunter Children's Hospital","New Lambton Heights",{"type":125,"coordinates":248},[249,250],151.69364,-32.92466,{"lat":250,"lon":249},{"facility":253,"status":119,"city":171,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":254,"geoPoint":256,"contacts":50},"Perth Children's Hospital",{"type":125,"coordinates":255},[176,177],{"lat":177,"lon":176},{"facility":258,"status":119,"city":259,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":260,"geoPoint":264,"contacts":50},"The Alfred","Prahran",{"type":125,"coordinates":261},[262,263],144.99318,-37.85114,{"lat":263,"lon":262},{"facility":266,"status":197,"city":267,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":268,"geoPoint":272,"contacts":50},"Sydney Children's Hospital","Randwick",{"type":125,"coordinates":269},[270,271],151.24895,-33.91439,{"lat":271,"lon":270},{"facility":274,"status":119,"city":132,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":275,"geoPoint":277,"contacts":50},"Mater Adult Hospital",{"type":125,"coordinates":276},[137,138],{"lat":138,"lon":137},{"facility":279,"status":197,"city":280,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":281,"geoPoint":285,"contacts":50},"Macquarie University Hospital","Sydney",{"type":125,"coordinates":282},[283,284],151.20732,-33.86785,{"lat":284,"lon":283},{"facility":287,"status":197,"city":288,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":289,"geoPoint":293,"contacts":50},"The Children's Hospital at Westmead","Westmead",{"type":125,"coordinates":290},[291,292],150.98768,-33.80383,{"lat":292,"lon":291},{"facility":295,"status":197,"city":288,"state":50,"zip":50,"country":122,"countryCode":123,"cosmosGeoPoint":296,"geoPoint":298,"contacts":50},"Westmead Hospital",{"type":125,"coordinates":297},[291,292],{"lat":292,"lon":291},{"facility":300,"status":119,"city":301,"state":50,"zip":50,"country":302,"countryCode":303,"cosmosGeoPoint":304,"geoPoint":308,"contacts":50},"Rigshospitalet","Copenhagen","Denmark","DK",{"type":125,"coordinates":305},[306,307],12.56553,55.67594,{"lat":307,"lon":306},{"facility":310,"status":197,"city":311,"state":50,"zip":50,"country":312,"countryCode":313,"cosmosGeoPoint":50,"geoPoint":50,"contacts":50},"Soroka Medical Centre","Beer-Sheeva","Israel","IL",{"facility":315,"status":197,"city":316,"state":50,"zip":50,"country":312,"countryCode":313,"cosmosGeoPoint":317,"geoPoint":321,"contacts":50},"Carmel Medical Centre","Haifa",{"type":125,"coordinates":318},[319,320],34.99928,32.81303,{"lat":320,"lon":319},{"facility":323,"status":197,"city":316,"state":50,"zip":50,"country":312,"countryCode":313,"cosmosGeoPoint":324,"geoPoint":326,"contacts":50},"Rambam Health Care Campus",{"type":125,"coordinates":325},[319,320],{"lat":320,"lon":319},{"facility":328,"status":197,"city":329,"state":50,"zip":50,"country":312,"countryCode":313,"cosmosGeoPoint":330,"geoPoint":334,"contacts":50},"Hadassah Ein Kerem Hospital","Jerusalem",{"type":125,"coordinates":331},[332,333],35.21633,31.76904,{"lat":333,"lon":332},{"facility":336,"status":197,"city":337,"state":50,"zip":50,"country":312,"countryCode":313,"cosmosGeoPoint":338,"geoPoint":342,"contacts":50},"Schneider","Petah Tikva",{"type":125,"coordinates":339},[340,341],34.88747,32.08707,{"lat":341,"lon":340},{"facility":344,"status":197,"city":345,"state":50,"zip":50,"country":312,"countryCode":313,"cosmosGeoPoint":50,"geoPoint":50,"contacts":50},"Sheba Medical Centre","Ramat Gan Tel Aviv",{"facility":347,"status":197,"city":348,"state":50,"zip":50,"country":349,"countryCode":350,"cosmosGeoPoint":351,"geoPoint":355,"contacts":50},"Erasmus MC Sophia Children's Hospital","Rotterdam","Netherlands","NL",{"type":125,"coordinates":352},[353,354],4.47917,51.9225,{"lat":354,"lon":353},{"facility":357,"status":197,"city":358,"state":50,"zip":359,"country":358,"countryCode":360,"cosmosGeoPoint":361,"geoPoint":365,"contacts":50},"Tan Tock Seng Hospital Pte Ltd","Singapore","308433","SG",{"type":125,"coordinates":362},[363,364],103.85007,1.28967,{"lat":364,"lon":363},{"facility":367,"status":197,"city":368,"state":50,"zip":50,"country":369,"countryCode":370,"cosmosGeoPoint":371,"geoPoint":375,"contacts":50},"Kaohsiung Medical University Hospital","Kaohsiung City","Taiwan","TW",{"type":125,"coordinates":372},[373,374],120.31333,22.61626,{"lat":374,"lon":373},{"facility":377,"status":197,"city":378,"state":50,"zip":50,"country":369,"countryCode":370,"cosmosGeoPoint":379,"geoPoint":383,"contacts":50},"National Taiwan University Hospital","Taipei",{"type":125,"coordinates":380},[381,382],121.52639,25.05306,{"lat":382,"lon":381},{"facility":385,"status":197,"city":386,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":389,"geoPoint":393,"contacts":50},"Belfast City Hospital","Belfast","United Kingdom","UK",{"type":125,"coordinates":390},[391,392],-5.92541,54.59682,{"lat":392,"lon":391},{"facility":395,"status":197,"city":396,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":397,"geoPoint":401,"contacts":50},"Birmingham Children's Hospital","Birmingham",{"type":125,"coordinates":398},[399,400],-1.89983,52.48142,{"lat":400,"lon":399},{"facility":403,"status":197,"city":396,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":404,"geoPoint":406,"contacts":50},"Birmingham Heartlands Hospital",{"type":125,"coordinates":405},[399,400],{"lat":400,"lon":399},{"facility":408,"status":197,"city":409,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":410,"geoPoint":414,"contacts":50},"Bristol Royal Hospital for Children","Bristol",{"type":125,"coordinates":411},[412,413],-2.59665,51.45523,{"lat":413,"lon":412},{"facility":416,"status":197,"city":417,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":418,"geoPoint":422,"contacts":50},"Noah's Ark Childrens Hospital for Wales","Cardiff",{"type":125,"coordinates":419},[420,421],-3.18,51.48,{"lat":421,"lon":420},{"facility":424,"status":197,"city":425,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":426,"geoPoint":430,"contacts":50},"Royal Hospital for Children and Young People, Edinburgh","Edinburgh",{"type":125,"coordinates":427},[428,429],-3.19648,55.95206,{"lat":429,"lon":428},{"facility":432,"status":197,"city":425,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":433,"geoPoint":435,"contacts":50},"Western General Hospital",{"type":125,"coordinates":434},[428,429],{"lat":429,"lon":428},{"facility":437,"status":197,"city":438,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":439,"geoPoint":443,"contacts":50},"Queen Elizabeth University Hospital, Glasgow","Glasgow",{"type":125,"coordinates":440},[441,442],-4.25763,55.86515,{"lat":442,"lon":441},{"facility":445,"status":197,"city":446,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":447,"geoPoint":451,"contacts":50},"Alder Hey Children NHS Foundation Trust","Liverpool",{"type":125,"coordinates":448},[449,450],-2.97794,53.41058,{"lat":450,"lon":449},{"facility":453,"status":197,"city":454,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":455,"geoPoint":459,"contacts":50},"Royal Brompton Hosptial","London",{"type":125,"coordinates":456},[457,458],-0.12574,51.50853,{"lat":458,"lon":457},{"facility":461,"status":197,"city":462,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":463,"geoPoint":467,"contacts":50},"Royal Manchester Children's Hospital","Manchester",{"type":125,"coordinates":464},[465,466],-2.23743,53.48095,{"lat":466,"lon":465},{"facility":469,"status":197,"city":470,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":471,"geoPoint":475,"contacts":50},"Nottingham Children's Hosptial","Nottingham",{"type":125,"coordinates":472},[473,474],-1.15047,52.9536,{"lat":474,"lon":473},{"facility":477,"status":197,"city":470,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":478,"geoPoint":480,"contacts":50},"Queens Medical Centre",{"type":125,"coordinates":479},[473,474],{"lat":474,"lon":473},{"facility":482,"status":197,"city":470,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":483,"geoPoint":485,"contacts":50},"Welcome Wolfson Adult CF Centre (City Hospital Campus)",{"type":125,"coordinates":484},[473,474],{"lat":474,"lon":473},{"facility":487,"status":197,"city":488,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":489,"geoPoint":493,"contacts":50},"University Hospital Llandough","Penarth",{"type":125,"coordinates":490},[491,492],-3.17342,51.4386,{"lat":492,"lon":491},{"facility":495,"status":197,"city":496,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":497,"geoPoint":501,"contacts":50},"Southampton General Hospital","Southampton",{"type":125,"coordinates":498},[499,500],-1.40428,50.90395,{"lat":500,"lon":499},{"facility":503,"status":197,"city":504,"state":50,"zip":50,"country":387,"countryCode":388,"cosmosGeoPoint":505,"geoPoint":509,"contacts":50},"Wythenshawe Hospital","Wythenshawe",{"type":125,"coordinates":506},[507,508],-2.2654,53.38027,{"lat":508,"lon":507},{"type":511,"investigatorFullName":512,"investigatorTitle":513,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Claire Wainright","Professor",[515,518,520,522,524,526,528,530,532,534,536,538],{"name":516,"class":517},"Australian Government Department of Health and Ageing","OTHER_GOV",{"name":519,"class":6},"Children's Hospital Foundation",{"name":521,"class":6},"Cystic Fibrosis Foundation",{"name":523,"class":6},"Newcastle University",{"name":525,"class":6},"Griffith University",{"name":527,"class":6},"Erasmus Medical Center",{"name":529,"class":6},"Monash University",{"name":531,"class":6},"University of Copenhagen",{"name":533,"class":6},"South Australian Health and Medical Research Institute",{"name":535,"class":6},"University of Melbourne",{"name":537,"class":6},"Murdoch Childrens Research Institute",{"name":539,"class":6},"QIMR Berghofer Medical Research Institute","100386376","phase-2-finding-the-optimal-regimen-for-mycobacterium-abscessus-treatment-100386376",false,"NCT04310930","Finding the Optimal Regimen for Mycobacterium Abscessus Treatment","Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT)","FORMaT","Eligibility criteria for the FORMaT trial can be applied at two levels:\n\n1. Eligibility into the Intervention Program, or;\n2. Eligibility into the Observational Cohort.\n\nPotential participants can only be enrolled in either the Intervention Program or the Observational Cohort at any one time. Provided the eligibility criteria are met, potential participants may either:\n\n1. Enrol directly into the Intervention Program, or;\n2. Enrol into the Observational Cohort and transition into the Intervention Program once they satisfy the inclusion criteria for this program which can occur at any time during the trial.\n\nEligibility into the FORMaT trial will be assessed at screening. Observational Cohort participants who go on to meet the Intervention Program eligibility criteria can transition from the Observational Cohort to the Intervention Program.\n\nINTERVENTION PROGRAM ELIGIBILITY (APPENDIX A) Potential participants are eligible for the Intervention Program (Appendix A) if the criteria below are met. Eligible participants with mixed NTM infections (slow growers + MABS) or with recurrence of MABS infection following completion of previous treatment will be eligible if they meet the inclusion and exclusion criteria listed below. For eligible participants with mixed NTM infections additional therapy combinations are available as detailed in the relevant appendices.\n\nINTERVENTION PROGRAM INCLUSION CRITERIA\n\n1. Positive MABS-PD diagnosis meeting all three American Thoracic Society clinical, radiological and microbiological diagnostic criteria for MABS-PD. Defined as:\n\n   1. Clinical: Pulmonary symptoms and exclusion of other diagnoses.\n   2. Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal bronchiectasis with multiple small nodules.\n   3. Microbiological: MABS positive culture results from at least two separate expectorated sputum samples.\n\n   or Positive culture results from at least one bronchial wash or lavage. or Transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli (AFB)) and positive culture for NTM or biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and one or more sputum or bronchial washes that are culture positive for NTM.\n\n   Screening samples must be collected within the timeframes stated in the relevant appendix.\n2. Male or female participants of any age.\n3. Participant has not received treatment for MABS-PD in the 12 months preceding assessment of eligibility or as specified in the relevant appendix (this includes drugs prescribed for the treatment of other mycobacteria and\u002For other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List Standard Operating Procedure (SOP)).\n4. Informed consent signed by participant or parent\u002Flegal guardian if participant is under 18 years of age.\n5. Ability to comply with study visits, therapies and study procedures as judged by the site investigator.\n\nINTERVENTION PROGRAM EXCLUSION CRITERIA\n\n* Participants receiving current treatment for MABS (this includes drugs prescribed for the treatment of other mycobacteria and\u002For other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List SOP), except for participants taking azithromycin as part of routine treatment for CF or chronic infection-related pulmonary disease, or as specified in the relevant appendix.\n* Participants who have a QTc interval of \\>500 milliseconds (QT interval corrected based on Fridericia method).\n* Participants who are pregnant or planning to continue breast feeding.\n* Known hypersensitivity or contraindication to any of the therapies for which no alternative option(s) have been provided.\n\nOBSERVATIONAL COHORT INCLUSION CRITERIA\n\nTo be eligible to participate in the Observational Cohort the following criteria must be met:\n\n1. Male and female participants of any age with at least one positive respiratory culture for MABS.\n2. Informed consent signed by participant or parent\u002Flegal guardian if participant is under 18 years of age.\n3. Ability to comply with study visits and study procedures as judged by the site investigator.\n\nOBSERVATIONAL COHORT EXCLUSION CRITERIA\n\nPotential participants will be ineligible to participate in the Observational Cohort if any of the following criterion are met:\n\n• Receiving active treatment for MABS within the previous 12 months (this includes drugs prescribed for the treatment of other mycobacteria and\u002For other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List SOP, except for participants taking azithromycin as part of routine treatment for CF or chronic infection-related pulmonary disease).\n\nADDITIONAL ELIGIBILITY CRITERIA Mixed NTM infections Participants who have cultured slow growing NTM of the same species two or more times in the 24 months prior to screening, with one of those cultures within the 6 months prior to screening, will be considered to have mixed NTM infection at the time of screening. The participants must meet all other inclusion criteria and no exclusion criteria to be eligible for participation. Ethambutol may be used in addition to trial therapies to cover mixed NTM infections considered to require treatment by their clinician.\n\nAppendix specific sub-studies and integrated studies Appendix specific sub-studies and integrated studies may have additional eligibility criteria which are described in each of the relevant appendices.","ALL",{"count":550,"type":551},300,"ESTIMATED","INTERVENTIONAL",[554,555],"PHASE2","PHASE3","Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.",[558],"Pulmonary Disease Due to Mycobacteria (Diagnosis)",[560,561,562,563,564,565,566,567],"Mycobacterium abscessus","Pulmonary disease","Microbiological","Regimen","Radiological","Quality of life","Health economics","Biomarkers","2026-05-06",{"date":570,"type":571},"2026-05-11","ACTUAL",{"date":573,"type":571},"2020-03-02",{"date":575,"type":551},"2030-06-30",{"name":5,"class":6},50]