[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mycobacterium-infections-nontuberculous\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mycobacterium-infections-nontuberculous":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100600224","phase-2-safety-immunogenicity-and-efficacy-of-therapeutic-mycobacterium-bovis-bcg-boost-100600224",false,"NCT07094711","Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)","Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG in Patients With Mycobacterium Avium Complex Lung Disease (BOOST)","BOOST","Inclusion Criteria\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female aged ≥18 years\n2. Mycobacterium avium complex lung disease as evidenced by diagnosis or treatment for MAC lung disease by pulmonologist or infectious disease physician in the medical record. The following data will be extracted from the medical record:\n\n   1. History of at least 2 MAC positive respiratory cultures, one of which is within 1 year of enrollment. In the event a MAC positive culture is from bronchial lavage or biopsy, one culture rather than 2 will meet criteria.\n   2. Respiratory and\u002For constitutional symptoms consistent with MAC lung disease\n   3. Nodular or cavitary opacities on chest radiograph or bronchiectasis with multiple small nodules on high-resolution computed tomography\n3. Provision of signed and dated informed consent form\n4. Stated willingness to comply with all study procedures\n5. Women of childbearing potential (WOCBP) (i.e., fertile following menarche and until becoming postmenopausal unless permanently sterile) agree to practice a highly effective method of birth control from Day 0 to at least 90 days after study intervention. Some examples of acceptable birth controls are:\n\n   1. True abstinence (refraining from heterosexual intercourse during the entire study),\n   2. Copper intrauterine device (IUD),\n   3. Hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill \\[combined with barrier method\\]), exclusive homosexual relationship) sole male partner who has undergone surgical sterilization\n\nExclusion Criteria\n\nSelection of study participants will be equitable, but an individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Currently receiving antibiotics prescribed for their MAC lung disease\n2. Having received any antibacterial antibiotics within the past 14 days prior to study vaccination, day 0\n3. Known allergy, intolerance or other contraindication to isoniazid or rifampin or ethambutol\n4. Expectation of starting anti-MAC lung disease antibiotics in the next 2 months per patient or their physician\n5. Persons with congenital or acquired immune deficiencies (e.g., HIV infection; leukemia, lymphoma, or cancer therapy within the past 2 years; immunosuppressive therapy such as anti B cell depleting therapies, corticosteroids (\\>20 mg\u002Fday for \\> 14 days), dupilumab, elivaldogene, etrasimod, cytotoxic chemotherapy, miscellaneous oncologic agents, therapeutic immunosuppressant agents, methotrexate, teplizumab, tezepelumab, tildrakizumab, tralokinumab, ustekinumab). Persons with lung and other solid organ transplants\u002Fhematologic stem cell transplants who may be contraindicated to receive a live vaccine. Point of care HIV testing must be negative at baseline.\n6. Prior BCG Vaccination. If unknown Bcgatlas.org shall be consulted for local vaccination administration policies.\n7. Known pregnancy at the time of screening or breastfeeding at the time of enrollment (pregnancy test negative at baseline if applicable)\n8. Cystic fibrosis\n9. Active tuberculosis: Active tuberculosis (respiratory AFB culture growing Mycobacterium tuberculosis complex within the past 4 months).\n10. Known exposure to a case of active pulmonary tuberculosis within 10 weeks of enrollment\n11. Known prior hypersensitivity reaction to BCG or any component of the BCG vaccine\n12. Received live injectable vaccine within 28 days of day 0 study vaccination\n13. Any condition in the opinion of the investigator that may confound the study endpoints Note that colonization or co-infection with other nontuberculous mycobacteria is not exclusionary, as MAC will be the endpoint.","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to find out if the Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine can be used safely to treat Mycobacterium avium complex (MAC) lung disease.\n\nResearchers will compare responses from patients with MAC lung disease after receiving an injection of BCG or placebo (a look-alike substance that contains no drug)\n\nParticipants in the study:\n\n* Receive a BCG or placebo injection at UVA study center on Day 0\n* Come to UVA study center on Day 60\n* Come to UVA study center at the end of the study\n* Answer surveys and questionnaires about how you are doing\n* Have blood drawn 3 times, on injection day, day 60, and at end of study\n* Give the study team personal and demographic information\n* Discuss any new symptoms with the study team\n* Provide monthly sputum samples per usual care",[27,28],"Mycobacterium Avium-intracellulare Infection","Mycobacterium Infections, Nontuberculous","RECRUITING","2026-05-26",{"date":32,"type":33},"2026-05-27","ACTUAL",{"date":35,"type":33},"2026-04-27",{"date":37,"type":21},"2028-12-30",{"name":39,"class":40},"University of Virginia","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":41},"100536562","m-avium-wgs-during-mav-pd-treatment-100536562","NCT06266442","M. Avium WGS During Mav-PD Treatment","Longitudinal Assessment of Clinical Pulmonary Mycobacterium Avium Isolates in Treated Patients Using Whole Genome Sequencing","Inclusion Criteria:\n\n* Age 18 and older\n* Willing to provide informed consent and participate in study procedures\n* Residing continuously in Ontario during the past five years\n* Mav-PD, either initial or recurrent (previously treated patients will be eligible) five years\n* Meet American Thoracic Society (ATS) \u002F Infectious Diseases Society of America (IDSA) NTM disease criteria for Mav-PD\n\nExclusion Criteria:\n\n* Lack of an available pre-treatment M. avium isolate in the PHOL isolate bank\n* The inability to produce sputum either spontaneously or by induction with nebulized hypertonic saline\n* Cavitation \\>3 cm internal diameter\n* Known macrolide-resistant MAC infection\n* HIV infection\n* Known diagnosis of cystic fibrosis\n* History of solid organ or hematological transplantation\n* Severe comorbid illness that is reasonably expected to limit survival to \\\u003C24 months\n* Residing in mid\u002Fnorth York region (King, Aurora, Newmarket, Whitechurch-Stouffville, East Gwillimbury or Georgina)\n* Having moved between regions (Toronto\u002Fsouthern York region vs non-Toronto\u002FYork region vs mid-northern York region) within the past 5 years",{"count":50,"type":21},40,"OBSERVATIONAL","This is a prospective observational study using whole genome sequencing (WGS) to investigate whether new strains (other than the initially identified strain(s)) of M. avium are responsible for persistently culture positive sputum during treatment (refractory disease), or the reversion to culture positive sputum after prior conversion to negative. The study will further investigate for differences between participants living in the Toronto\u002FYork region versus participants living elsewhere.\n\nThe primary goal of this prospective observational study is to understand why some patients with M. avium lung disease have persistent or recurrent M. avium in their sputum despite treatment. The aim is to understand whether it is usually due to treatment failure or new infection.",[54,28,55,56,57],"Mycobacterium Avium","Mycobacterium Infections","Nontuberculous Mycobacterial Lung Disease","Respiratory Tract Diseases",[59,60,61],"Nontuberculous mycobacterium","Whole genome sequencing","Mycobacterium avium","2024-05-17",{"date":64,"type":33},"2024-05-21",{"date":66,"type":33},"2024-05-13",{"date":68,"type":21},"2026-09",{"name":70,"class":40},"University Health Network, Toronto"]