[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mycobacterium-abscessus-pulmonary-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mycobacterium-abscessus-pulmonary-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"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":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Mycobacterium Abscessus Pulmonary Disease","Mycobacterium Abscessus Infection","Non-Tuberculous Mycobacterial (NTM) Infections","Non-Tuberculous Mycobacteria Pulmonary Disease",[32,33,34],"adaptive platform trial","dual beta lactam","sulbactam-durlobactam","NOT_YET_RECRUITING","2026-03-16",{"date":38,"type":39},"2026-03-20","ACTUAL",{"date":41,"type":21},"2027-04",{"date":43,"type":21},"2031-07",{"name":45,"class":46},"The University of Queensland","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100615694","phase-2-tcm-as-an-adjuvant-treatment-in-mycobacterium-abscessus-pulmonary-disease-100615694","NCT07295938","TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease","A Study to Assess the Traditional Chinese Medicine as Adjunctive Therapy to Improve Cure Rates During the Continuation Phase in Mycobacterium Abscessus Pulmonary Disease","Inclusion Criteria:\n\n* Patient diagnosed with Mycobacterium abscessus pulmonary disease;\n* Patients have completed the initial phase of treatment as recommended by the guidelines;\n* Patients who have given written informed consent\n* One week prior to enrollment, organ function levels must meet the following criteria: a. Hemoglobin ≥60g\u002FL; b. Neutrophil count ≥0.5×10\\^9\u002FL; c. Platelet count ≥60×10\\^9\u002FL; d. Serum total bilirubin ≤3 times the upper limit of normal; e. Aspartate aminotransferase ≤3 times the upper limit of normal; f. Alanine aminotransferase ≤3 times the upper limit of normal; g. Creatinine level below 2 times the upper limit of normal or creatinine clearance ≥60mL\u002Fmin; h. Urea nitrogen ≤200mg\u002FL; i. Urinary protein \\\u003C++, with ≥500mg total protein in 24-hour urine if protein is present; j. Blood glucose: within normal range and\u002For stable blood glucose control in diabetic patients; k. Cardiac function: no history of myocardial infarction within 6 months; no unstable angina; no severe arrhythmia.\n\nExclusion Criteria:\n\n* Patients with a drug allergy to the investigational medication;\n* Patients infected with two or more non-tuberculous mycobacteria, or those with active pulmonary tuberculosis;\n* Patients with a prior history of pulmonary parenchymal organ transplantation;\n* Patients with severe conditions such as congenital or acquired immunodeficiency disorders, active malignant tumors (primary or metastatic), or any malignancies requiring chemotherapy or radiotherapy during screening or study;\n* Patients undergoing dialysis;\n* Patients with radiation pneumonitis requiring corticosteroid or immunoglobulin pulse therapy, or clinically proven active interstitial lung disease, uncontrolled massive pleural effusion, or pericardial effusion;\n* Unstable systemic comorbidities (hypertensive crisis, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, severe hepatic or renal dysfunction, neuropsychiatric conditions such as Alzheimer's disease);\n* Patients with intestinal dysfunction or malabsorption syndrome;\n* Pregnant or breastfeeding women;\n* Patients receiving other investigational drugs within 4 weeks prior to first exposure to the study drug;\n* Concurrent enrollment in another clinical trial, except for observational (non-interventional) studies or follow-up visits in interventional trials;\n* Physical examinations or clinical tests that the investigator deems potentially interfering with results or increasing treatment-related complications.","18 Years","75 Years",{"count":57,"type":21},352,[24],"Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD). The investigators aimed to evaluate the efficacy of Chinese herbs as adjunct therapy to improve cure rates or reduce recurrence rates during the continuation phase of MAB-PD treatment.",[27],[62,63,64],"Mycobacterium abscessus Pulmonary Disease","Continuation Phase","TCM","RECRUITING","2025-12-19",{"date":68,"type":39},"2025-12-22",{"date":70,"type":39},"2025-09-08",{"date":72,"type":21},"2028-11",{"name":74,"class":46},"Shanghai University of Traditional Chinese Medicine",8]