[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630233":3},{"organization":4,"armGroups":7,"interventions":52,"overallOfficials":58,"centralContacts":127,"locations":58,"responsibleParty":137,"collaborators":139,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":58,"enrollmentInfo":153,"targetDuration":58,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":165,"overallStatus":169,"whyStopped":58,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":58},{"fullName":5,"class":6},"The University of Queensland","OTHER",[8,26,35,40,44,48],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen","EXPERIMENTAL","Weeks 1 to 4 (and Weeks 7 to 10 if randomised to Prolonged Intensive)\n\n1. IV sulbactam-durlobactam\n2. IV ceftriaxone\n3. Oral amoxicillin\n4. Oral azithromycin or clarithromycin\n5. Oral clofazimine. Weeks 5 to 6 (and Weeks 8 to 12 if randomised to Prolonged Intensive)\n\n1\\. Oral clofazimine, and; 2. Oral azithromycin or clarithromycin, and; 3. In combination with one to three of the following oral antibiotics guided by participant susceptibility and tolerance:\n\n* Linezolid,\n* Trimethoprim \u002F sulfamethoxazole (co-trimoxazole),\n* Bedaquiline,\n* Rifabutin,\n* Doxycycline,\n* Moxifloxacin.",[13,14,15,16,17,18,19,20,21,22,23,24,25],"Drug: Sulbactam 25mg\u002Fkg -Durlobactam 25mg\u002Fkg (Every 6 hours)","Drug: Ceftriaxone for Injection","Drug: Amoxicillin","Drug: Azithromcyin","Drug: clarithromycin","Drug: Clofazimine","Drug: Ethambutol","Drug: linezolid","Drug: Trimethoprim \u002F Sulfamethoxazole","Drug: Doxycycline","Drug: moxifloxacin","Drug: bedaquiline","Drug: Rifabutin",{"label":27,"type":28,"description":29,"interventionNames":30},"Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine","ACTIVE_COMPARATOR","1. IV amikacin, and;\n2. IV tigecycline, and;\n3. IV imipenem\u002Fcilastatin or IV cefoxitin, and;\n4. Oral azithromycin or oral clarithromycin, and;\n5. Oral clofazimine. Administered for a duration of 6 weeks for Short Intensive Therapy or 12 weeks for Prolonged Intensive Therapy.",[16,17,18,19,31,32,33,34],"Drug: Amikacin Injection","Drug: tigecycline","Drug: Imipenem + Cilastatin","Drug: Cefoxitin",{"label":36,"type":10,"description":37,"interventionNames":38},"Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine","1. Inhaled amikacin, and;\n2. IV tigecycline, and;\n3. IV imipenem\u002Fcilastatin or IV cefoxitin, and;\n4. Oral azithromycin or oral clarithromycin, and;\n5. Oral clofazimine. Administered for a duration of 6 weeks for Short Intensive Therapy or 12 weeks for Prolonged Intensive Therapy.",[16,17,18,19,32,33,34,39],"Drug: Amikacin (Inhalation)",{"label":41,"type":10,"description":42,"interventionNames":43},"Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide","1. IV amikacin, and;\n2. IV tigecycline, and;\n3. IV imipenem\u002Fcilastatin or IV cefoxitin, and;\n4. Oral azithromycin or oral clarithromycin. Administered for a duration of 6 weeks for Short Intensive Therapy or 12 weeks for Prolonged Intensive Therapy.",[16,17,19,31,32,33,34],{"label":45,"type":28,"description":46,"interventionNames":47},"Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents","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. For 46 weeks after completion of Intensive Therapy phase.",[16,17,18,19,20,21,22,23,24,25],{"label":49,"type":10,"description":50,"interventionNames":51},"Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents","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. For 46 weeks after completion of Intensive Therapy phase.",[16,17,18,19,39,20,21,22,23,24,25],[53,59,63,67,71,75,79,83,87,91,95,99,103,107,111,115,119,123],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","Sulbactam 25mg\u002Fkg -Durlobactam 25mg\u002Fkg (Every 6 hours)","Adults and Children 12 years and older: IV sulbactam\u002Fdurlobactam Greater than or equal to 130ml\u002Fmin Every FOUR (4) hourly. Administered by intravenous infusion over 3 hours.\n\nFor CrCL 45 to 129ml\u002Fmin 1g sulbactam\u002F 1g durlobactam Every SIX (6) hourly. Administer by intravenous infusion over 3 hours.\n\nFor CrCL 30 to 44ml\u002Fmin\n\n1g sulbactam\u002F 1g durlobactam Every EIGHT (8) hourly. Administer by intravenous infusion over 3 hours.\n\nFor CrCL 15 to 29ml\u002Fmin 1g sulbactam\u002F 1g durlobactam Every TWELVE (12) hourly. Administer by intravenous infusion over 3 hours.\n\nFor CrCL\\\u003C15ml\u002Fmin\n\n1g sulbactam\u002F 1g durlobactam Every TWELVE (12) hourly for first 3 doses then reduce to every 24 hourly thereafter. Administer by intravenous infusion over 3 hours.",[9],null,{"type":54,"name":60,"description":61,"armGroupLabels":62,"otherNames":58},"Ceftriaxone for Injection","Adults and Children 12 years and older: IV ceftriaxone\n\n1g Every TWELVE (12) hourly",[9],{"type":54,"name":64,"description":65,"armGroupLabels":66,"otherNames":58},"Amoxicillin","Adults and Children 12 years and older: Oral amoxicillin 1000mg Three times daily",[9],{"type":54,"name":68,"description":69,"armGroupLabels":70,"otherNames":58},"Azithromcyin","Adults and Children 12 years and older: Oral Azithromycin 250 - 500mg Once daily If \\\u003C40kg or poorly tolerated 250mg Once daily",[45,49,27,36,41,9],{"type":54,"name":72,"description":73,"armGroupLabels":74,"otherNames":58},"clarithromycin","Oral clarithromycin. Only for use if azithromycin not tolerated. Adults: 500mg twice daily. Children: 12-18 years of age: Dosing independent of weight 500mg twice daily",[45,49,27,36,41,9],{"type":54,"name":76,"description":77,"armGroupLabels":78,"otherNames":58},"Clofazimine","Adults and Children 12 years and older: Oral clofazimine 100mg to 300mg Once daily",[45,49,27,36,9],{"type":54,"name":80,"description":81,"armGroupLabels":82,"otherNames":58},"Ethambutol","For participants with confirmed mixed NTM (slow growers + MABS) infections, there is an option to add oral ethambutol to the treatment arm in accordance with the dosing below.\n\nOral ethambutol 15mg\u002Fkg (rounded to account for tablet strength) OR Once daily 25mg\u002Fkg (rounded to account for tablet strength) Thrice weekly",[45,49,27,36,41,9],{"type":54,"name":84,"description":85,"armGroupLabels":86,"otherNames":58},"Amikacin Injection","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",[27,41],{"type":54,"name":88,"description":89,"armGroupLabels":90,"otherNames":58},"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",[27,36,41],{"type":54,"name":92,"description":93,"armGroupLabels":94,"otherNames":58},"Imipenem + Cilastatin","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).",[27,36,41],{"type":54,"name":96,"description":97,"armGroupLabels":98,"otherNames":58},"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.",[27,36,41],{"type":54,"name":100,"description":101,"armGroupLabels":102,"otherNames":58},"Amikacin (Inhalation)","Adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily. PLEASE NOTE: low preservative intravenous amikacin preparation to be used as inhalation, NOT liposomal amikacin.",[49,36],{"type":54,"name":104,"description":105,"armGroupLabels":106,"otherNames":58},"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: \\>12 years 600mg once daily.",[45,49,9],{"type":54,"name":108,"description":109,"armGroupLabels":110,"otherNames":58},"Trimethoprim \u002F Sulfamethoxazole","Adults and children 12 years and older: Oral Co-trimoxazole (Trimethoprim \u002F Sulfamethoxazole) 160\u002F800mg twice daily.",[45,49,9],{"type":54,"name":112,"description":113,"armGroupLabels":114,"otherNames":58},"Doxycycline","Adults and Children 12 years and older: Oral doxycycline 100mg once daily.",[45,49,9],{"type":54,"name":116,"description":117,"armGroupLabels":118,"otherNames":58},"moxifloxacin","Adult: Oral moxifloxacin 400mg once daily. Children 12 years and older: Oral moxifloxacin 10-15mg\u002Fkg once daily, maximum dose 400mg",[45,49,9],{"type":54,"name":120,"description":121,"armGroupLabels":122,"otherNames":58},"bedaquiline","Adult: 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).",[45,49,9],{"type":54,"name":124,"description":125,"armGroupLabels":126,"otherNames":58},"Rifabutin","Adult: Oral rifabutin: 5mg\u002Fkg once daily, maximum 300-450mg. Children 12 years and older: Oral rifabutin 5mg\u002Fkg once daily",[45,49,9],[128,133],{"name":129,"role":130,"phone":131,"phoneExt":58,"email":132},"Claire Wainwright Chief Investigator, MD","CONTACT","+61730697322","claire.wainwright@health.qld.gov.au",{"name":134,"role":130,"phone":135,"phoneExt":58,"email":136},"Tiffany Jong Project Manager, BPharm","+61730697620","formattrial@health.qld.gov.au",{"type":138,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR",[140],{"name":141,"class":142},"Innoviva Specialty Therapeutics","INDUSTRY","100630233","phase-2-testing-a-novel-combination-treatment-arm-d-versus-standard-of-care-for-intensive-phase-treatment-for-mycobacterium-abscessus-pulmonary-disease-in-people-with-or-without-cystic-fibrosis-in-the-finding-the-optimal-regimen-for-mycobacterium-abscessus-treatment-format-adaptive-platform-trial-100630233",false,"NCT07485010","Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial","A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial","FORMaT-EVOLVE","Inclusion Criteria:\n\n1. Must meet eligibility criteria as per the FORMaT Master Protocol and Appendix A1 Inclusion Criteria (NCT04310930).\n2. Male or female participants aged 12 years and older.\n\nExclusion Criteria:\n\n1. Must not have any exclusion criteria as per the FORMaT Master Protocol and Appendix A1 Exclusion Criteria (NCT04310930).\n2. Participants aged \\\u003C12 years old.\n3. Participants aged between 12 and \\\u003C18years old with clinically significant renal impairment as indicated by an age-appropriate estimated creatinine clearance.\n4. Known hypersensitivity to any of the therapies for which no alternative option(s) have been provided. This includes:\n\n   * Sulbactam\u002Fdurlobactam\n   * Ceftriaxone,\n   * Amoxicillin,\n   * Macrolide antibiotics, and\n   * Clofazimine.","ALL","12 Years",{"count":154,"type":155},300,"ESTIMATED","INTERVENTIONAL",[158],"PHASE2","The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are:\n\n* How well does Arm D treat mycobacterium abscessus pulmonary disease?\n* What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects.\n\nParticipants will:\n\n* Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930)\n* Be given Arm D for 4 weeks or standard of care treatments for 6 weeks.\n* Be reviewed by the study doctors weekly for checkups and tests.\n* Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.",[161,162,163,164],"Mycobacterium Abscessus Pulmonary Disease","Mycobacterium Abscessus Infection","Non-Tuberculous Mycobacterial (NTM) Infections","Non-Tuberculous Mycobacteria Pulmonary Disease",[166,167,168],"adaptive platform trial","dual beta lactam","sulbactam-durlobactam","NOT_YET_RECRUITING","2026-03-16",{"date":172,"type":173},"2026-03-20","ACTUAL",{"date":175,"type":155},"2027-04",{"date":177,"type":155},"2031-07",{"name":5,"class":6}]