[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-tuberculous-mycobacteria-pulmonary-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-tuberculous-mycobacteria-pulmonary-disease":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100607757","health-impact-of-non-tuberculous-mycobacteria-pulmonary-disease-ntm-pd-100607757",false,"NCT07192705","Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD)","An Observational Cross-sectional Study Exploring Differences in Health Between People With Non-Tuberculous Mycobacteria Pulmonary Disease and People With Bronchiectasis Without NTM Pulmonary Infection.","Inclusion Criteria:\n\n\\- Age: 18 years or older, able to provide informed consent.\n\nNTM-PD Group:\n\n* Participants will be adults diagnosed with confirmed NTM-PD based on the British Thoracic Society (BTS) guidelines.\n* The participant should not be on any antimicrobial therapy (at least two weeks before participation) and should not have previously received or be currently on antimicrobial therapy for NTM-PD.\n\n  \\* BTS guidelines:\n* Clinical (both required):\n* Pulmonary symptoms, nodular or cavitary opacities on chest radiograph, or a high-resolution CT scan that shows multifocal bronchiectasis with multiple small nodules.\n* Appropriate exclusion of other diagnoses.\n* Microbiological:\n* A minimum of two positive expectorated sputum culture results of the same NTM species from samples collected on separate days within 12 months before recruitment.\n\nOR\n\n* Positive culture results from at least one bronchial wash or lavage. OR\n* Transbronchial or other lung biopsy with mycobacterial histopathological features (granulomatous inflammation or AFB) and positive culture for NTM or biopsy showing mycobacterial histopathological features (granulomatous inflammation or AFB) and one or more sputum or bronchial washings that are culture-positive for NTM.\n\nBronchiectasis Group:\n\n* Diagnosed with bronchiectasis, as confirmed in medical records based on clinical assessment, and radiological findings.\n* Never had a history of positive culture result for NTM pulmonary infection.\n* The latest NTM-negative result must be within the past 12 months from the study's start date or no earlier than 2024.\n\nExclusion Criteria:\n\n\\- Age: Under 18 years of age, or unable to provide informed consent.\n\nNTM-PD Group:\n\n* No confirmation of NTM-PD diagnosis.\n* Diagnosed with a reinfection of NTM-PD.\n* Started antimicrobial therapy for NTM-PD.\n\nBronchiectasis Group:\n\n* No diagnosis of bronchiectasis or diagnosis of bronchiectasis with NTM-PD.\n* Diagnosed with other chronic respiratory diseases considered primary conditions, rather than bronchiectasis.\n* Participants with a history of NTM pulmonary infection.\n* NTM-negative results obtained before 2024.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","OBSERVATIONAL","Nontuberculous mycobacteria (NTM) are environmental organisms found in soil and water. The majority do not cause human disease. When they do, this is mostly as a chronic lung infection in people with long-term lung problems such as chronic obstructive pulmonary disease (COPD), bronchiectasis, or cystic fibrosis. The number of people with NTM pulmonary disease (PD) is increasing, and its management can be complex, requiring prolonged treatment with multiple, often toxic, drugs in someone who may already be frail.\n\nNon-drug approaches, such as airway clearance techniques, structured exercise, nutritional support and psychological care are used to help manage bronchiectasis and COPD. However, there is limited evidence about their benefit in people with NTM-PD. Also, it is not clear whether these patients' health needs are different from people with bronchiectasis alone.\n\nThe investigators want to identify the most important symptoms encountered by people with NTM-PD and patient preferences for care. The study also aims to explore whether the need for non-drug measures differs between people with and without NTM-PD who have other underlying lung disease.\n\nThe research will take place at one NHS centre and involve a single assessment of 40 people with NTM-PD not using specific antibiotics to treat their NTM and 40 people with bronchiectasis but no evidence for NTM. Following consent, and mainly using questionnaires, participants will be asked about their physical and mental health, and nutritional status. Exercise capacity, muscle strength and body muscle\u002Ffat composition will also be assessed using simple tests. The total time required will be a maximum of one hour. Recruitment to the study will last around six months.\n\nThe results will help improve understanding of specific needs of people with NTM-PD and guide clinically relevant research in this area.",[24,25],"Non-Tuberculous Mycobacteria Pulmonary Disease","Bronchiectasis",[24,27,28,29,25,30,31,32],"NTM-PD","Non-Tuberculous Mycobacteria Lung Disease","Health Impact of NTM-PD","NTM-LD","Bronchiectasis without NTM-PD","Non-Pharmacological Intervention","RECRUITING","2026-05-13",{"date":36,"type":37},"2026-05-14","ACTUAL",{"date":39,"type":37},"2025-08-14",{"date":41,"type":20},"2026-06-01",{"name":43,"class":44},"University College, London","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"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","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.","12 Years",{"count":56,"type":20},300,"INTERVENTIONAL",[59],"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.",[62,63,64,24],"Mycobacterium Abscessus Pulmonary Disease","Mycobacterium Abscessus Infection","Non-Tuberculous Mycobacterial (NTM) Infections",[66,67,68],"adaptive platform trial","dual beta lactam","sulbactam-durlobactam","NOT_YET_RECRUITING","2026-03-16",{"date":72,"type":37},"2026-03-20",{"date":74,"type":20},"2027-04",{"date":76,"type":20},"2031-07",{"name":78,"class":44},"The University of Queensland"]