[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mycobacterium-avium-intracellulare-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mycobacterium-avium-intracellulare-infection":55},{"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":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":41},"100502648","drug-exposure-and-minimum-inhibitory-concentration-in-the-treatment-of-mac-lung-disease-100502648","NCT05824988","Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease","Drug Exposure and Minimum Inhibitory Concentration in the Treatment of Mycobacterium Avium Complex Lung Disease: a Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Culture-positive MAC lung disease\n* MAC treatment at the Shanghai Pulmonary Hospital\n* A regimen composed of at least the core drugs, i.e., macrolides, rifamycin and ethambutol, in doses not lower than recommended according to the ATS\u002FERS\u002FESCMID\u002FIDSA and Chinese national guidelines\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Confirmed mixed infection with mycobacterial species, including M.tuberculosis and other NTM species\n* Ongoing with any antimycobacterial treatment for more than one month, including tuberculosis and NTM\n* Patients admitted to the intensive care unit\n* Off-label use for any study drugs, such as inhalation of amikacin",{"count":50,"type":21},100,"OBSERVATIONAL","The incidence and prevalence of nontuberculous mycobacteria (NTM) infections have gradually increased over the years worldwide (1-3). In China, Mycobacterium avium complex (MAC) was the most prevalent NTM specie (4), while challenged by long treatment duration, frequent drug-induced adverse events, lack of treatment alternatives, poor treatment outcome and high recurrence rate (5, 6). In order to maximize the efficacy of the few available drugs and prevent the development of drug resistance, ensuring adequate plasma drug concentrations are of importance. Despite the role of pathogen susceptibility, determined by minimum inhibitory concentration (MIC), is non-negligible, the evidences regarding its association with treatment outcome are limited, especially for rifamycin and ethambutol. The difficulties in explaining the clinical values of MIC might partially be attributed to the lack of in vivo drug exposure data, which cannot be accurately predicted by the dose administered because of between-patient pharmacokinetic variability (7). Therapeutic drug monitoring (TDM) is a strategy to guide and personalize treatment by measuring plasma drug concentrations and pathogen susceptibility, which might have the potential to improve treatment response to MAC lung disease.\n\nIn this observational study, the hypothesis is that the drug exposure and\u002For MIC of antimycobacterial drugs are correlated to the treatment response of MAC lung disease, which is assessed from the perspective of treatment outcome, mycobacterial culture negative conversion, lung function, radiological presentation and self-reported quality of life. Consenting adult patients with culture-positive MAC lung disease will be recruited in study hospital. Respiratory samples (sputum and\u002For bronchoalveolar lavage fluid) will be collected regularly for mycobacterial culture on the basis of BACTEC MGIT 960 system and MIC will be determined using a commercial broth microdilution plate. Drug concentrations will be measured at 1 and\u002For 6 months after treatment initiation using liquid chromatography tandem mass spectrometry (LC-MS\u002FMS). The final treatment outcome is recorded at the end of MAC treatment and defined according to an NTM-NET consensus statement (8).",[54,55,56,57],"Mycobacterium Avium Complex","Mycobacterium Avium-Intracellulare Infection","Gram-Positive Bacterial Infections","Mycobacterium Infections",[59,60,61,62,63],"Treatment","Minimum Inhibitory Concentration","Drug Concentration","Pharmacokinetics","Pharmacodynamics","2024-01-19",{"date":66,"type":33},"2024-01-22",{"date":68,"type":33},"2023-04-14",{"date":70,"type":21},"2026-10",{"name":72,"class":40},"Shanghai Pulmonary Hospital, Shanghai, China"]