[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mycobacterium-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mycobacterium-infections":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,71,102,140,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":4,"leadSponsor":40,"locationsCount":43},"100059513","study-of-mycobacterial-infections-100059513",false,"NCT00018044","Study of Mycobacterial Infections","Natural History, Genetics, Phenotype, and Treatment of Mycobacterial Infections","* INCLUSION CRITERIA FOR PATIENTS:\n\nThis protocol will study patients with mycobacterial infections, including those without previously identified predisposing disease processes as well as individuals with underlying malignancies.\n\nPatients with nontuberculous mycobacterial infections will be of particular interest, as we are interested in isolating and characterizing the primary immune defect(s) responsible for this infection susceptibility.\n\nSelect patients with acquired immunodeficiencies or tuberculosis may also be studied if relevant host defects are suspected.\n\nPatients must be referred to NIH with a diagnosis or suspicion of having mycobacterial infection.\n\nMale and female patients will be accepted without limitations due to age.\n\nOnly patients with nontuberculous mycobacterial infections without HIV infection will be considered for long-term disease management.\n\nINCLUSION CRITERIA FOR RELATIVES:\n\nAs part of this protocol, we may obtain medical records, blood work, urine, saliva or buccal swab from some blood relatives of patients on the study, with the hope of isolating and characterizing the primary immune defect(s) responsible for mycobacterial infection susceptibilityand if there are any genetic links seen within families. We hope to identify families with an apparent genetic susceptibility to respiratory diseases predominantly associated with P-NTM and perform whole genome sequencing within this group to identify genetic mutations accounting for this increased susceptibility. Male and female patients will be accepted without limitation due to age. These relatives will not receive treatment or have any other protocol procedures done unless they become a patient on the study.\n\nEXCLUSION CRITERIA:\n\nNone.",true,"ALL","100 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","This study will examine the symptoms, course of disease and treatment of non-tuberculous mycobacterial (NTM) infections, as well as the genetics involved in these infections. Patients with NTM have recurrent lung infections and sometimes infections of the skin and other organs as well. They may also have curvature of the spine, barrel chest, and heart valve weakness. The study will compare the features of NTM with those of Job syndrome and cystic fibrosis, other diseases involving recurrent infections of the lungs and possibly other organs.\n\nPatients with diagnosed or suspected non-tuberculous mycobacterial infection, cystic fibrosis or Job syndrome may be eligible for this study. All participants will have a medical and family history, blood and urine tests, imaging studies that may include X-rays, computed tomography (CT) or magnetic resonance imaging (MRI) scans, and DNA and other genetic studies. In addition, all patients with Job syndrome and cystic fibrosis, and patients with NTM who have lung disease undergo the following procedures:\n\n* Scoliosis survey X-rays of the spine to look for curvature or other abnormalities of the spinal column\n* Echocardiography imaging test that uses sound waves to examine the heart chambers and valves\n* Electrocardiogram measurement of the electrical activity of the heart\n* Pulmonary function tests breathing tests to measure how much air the patient can move into and out of the lungs\n* Body measurements measurements of height, weight, arm span, finger length, etc.\n* Joint function assessment of joint mobility using different maneuvers to test flexibility of joints and ligaments\n* Examination of physical features that might be associated with NTM, such as high arched palate of the mouth, flat feet, or certain skin features\n* Dermatology (skin) examination for reactive skin conditions or other skin problems and possibly a skin biopsy (surgical removal of a small skin tissue sample for microscopic examination)\n* Interview with genetics specialist\n\nThese tests may require several days to complete. Patients with NTM will also be examined by a cystic fibrosis specialist and may have a sweat test. In addition, NTM patients will be asked to return to NIH every year for 5 years for follow-up tests, if medically indicated, including CT of the chest, scoliosis survey and examination by other specialists.\n\n...",[25],"Mycobacterium Infections",[27,28,29,30,31,32],"Mycobacterium Abscessus","Pulmonary","Mycobacterium Chelonae","Mycobacterium Avium Complex (MAC)","Nontuberculous Mycobacteria (NTM)","Natural History","RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2001-01-01",{"name":41,"class":42},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":4,"leadSponsor":70,"locationsCount":43},"100149071","training-protocol-on-the-natural-history-of-tuberculosis-100149071","NCT01212003","Training Protocol on the Natural History of Tuberculosis","Natural History of Tuberculosis","* INCLUSION CRITERIA:\n\nFOR ALL PATIENTS\n\nPatients may be included in this study who:\n\n* Have or are suspected to have TB infection.\n* Are aged 2 years or older.\n* Have a primary care physician, infectious diseases physician, pulmonologist, or TB specialist outside of the NIH who can provide care of his or her TB infection outside the NIH, provide directly observed therapy (DOT) if necessary, and monitor for side effects and toxicity of TB medications.\n* Are willing to consent to storage of specimens for future research.\n* Able to provide informed consent for themselves or, if they lack the capacity to provide informed consent, have an appropriate Legally Authorized Representative (LAR; the study team will comply with NIH Human Research Protection Program \\[HRPP\\] Policy 403).\n\nFOR PATIENTS WITH LATENT TB\n\nIn addition to the above-described inclusion criteria for all patients, patients may be included in the Latent TB part of this protocol who:\n\n-Have documented evidence of a positive purified protein derivative (PPD) skin test or Interferon-gamma Release Assays (IGRA) test meeting American Thoracic Society (ATS)\u002FCDC guidelines for latent TB; conversion can have occurred at any time.\n\nFOR PATIENTS WITH ACTIVE TB\n\nIn addition to the above-described inclusion criteria for all patients, patients may be included in the Active TB part of this protocol who:\n\n* Have active TB of any drug susceptibility pattern and any site of infection as determined by smear, culture, or biopsy.\n* Have appropriately documented clinically suspicious active TB without definitive microbiology confirmation.\n\nEXCLUSION CRITERIA:\n\nPatients will be excluded from this study who:\n\n* Are incarcerated.\n* Have been ordered by a court to take TB medications.\n* Are unwilling or unable to comply with prescribed therapy.\n* Are pregnant.\n\nEXCLUSION OF SPECIFIC POPULATIONS\n\nChildren: Children under the age of 2 are not eligible to enroll. The addition of the very young will not provide enough additional insights to justify the risk to this specific population.\n\nPregnant women: Pregnant women are not eligible for participation in this protocol because the study objectives can be achieved without the enrollment of this population. Enrolled participants who become pregnant during the study will be withdrawn.","2 Years",{"count":53,"type":21},150,"Background:\n\n\\- Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.\n\nObjectives:\n\n\\- To collect blood and other samples to study the natural history of tuberculosis.\n\nEligibility:\n\n\\- Individuals 2 years of age and older who have either active or latent tuberculosis.\n\nDesign:\n\n* Latent TB patients: Participants will have a single study visit with a physical examination and medical history, and will provide blood samples for testing.\n* Active TB patients: Participants will have an initial visit with a physical examination and medical history, and will provide blood samples for testing. Participants will also provide sputum samples if required, and may have an optional skin punch biopsy to collect a sample of skin tissue for study.\n* Treatment for active TB will be provided as part of this protocol.\n* Active TB participants may be asked to return for study visits every 1-2 months while receiving treatment....",[25,56,57,58,59],"Tuberculosis, Multidrug-Resistant","Latent Tuberculosis","Tuberculosis","Extensively Drug-Resistant Tuberculosis",[61,62,63,57,64,32,58],"TB","Mycobacterium Tuberculosis","Active Tuberculosis","MDR TB","2026-06-17",{"date":67,"type":37},"2026-06-18",{"date":69,"type":37},"2011-06-30",{"name":41,"class":42},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"100528052","transmission-and-acquisition-of-nontuberculous-mycobacteria-outbreak-investigation-transmit-100528052","NCT06155747","Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)","TrANsMIt","Inclusion Criteria:\n\n* Male or female participant of any age who has a history of NTM or a first positive NTM culture collected as part of routine clinical care from expectorated sputum, induced sputum and\u002For bronchoalveolar lavage.\n\nExclusion Criteria:\n\n* No NTM respiratory culture","1 Month","99 Years",{"count":81,"type":21},100,"The goal of this observational study is to support U.S. healthcare centers in determining if they may have an NTM outbreak among patients receiving care at the healthcare center. The study applies a standardized, reproducible outbreak investigation approach across diverse healthcare settings. This study focuses on patients with NTM isolates suspected to be part of an outbreak, receiving care at a specific U.S. healthcare center.\n\nThe main questions it aims to answer are:\n\nCan application of a standardized epidemiologic investigation framework support evaluation of whether clustered NTM infections may be consistent with healthcare-associated exposure? Are respiratory NTM isolates genetically related to environmental NTM isolates identified within healthcare settings or shared home water sources?\n\nResearchers will compare clinical, epidemiologic, molecular, and infection prevention data from suspected NTM isolates to determine whether patterns are consistent with healthcare-associated transmission or acquisition.\n\nParticipants (healthcare centers and selected patients) will:\n\n* Implement a standardized epidemiologic investigation using the Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria (HALT-NTM) toolkit\n* Submit available respiratory and environmental NTM isolates for molecular comparison, when applicable\n* Optionally collect dust and water biofilm samples within the healthcare setting\n* Complete a survey to provide home address history for watershed mapping, when clustered infections are identified",[84,85,86,25],"Nontuberculous Mycobacterial Pulmonary Infection","Outbreak Investigation","Healthcare Associated Infection",[88,84,89,86,90,91],"Epidemiology","Outbreak investigation","Infection transmission","Infection acquisition","2026-05-20",{"date":94,"type":37},"2026-05-26",{"date":96,"type":37},"2023-03-01",{"date":98,"type":21},"2036-12-28",{"name":100,"class":101},"University of North Carolina, Chapel Hill","OTHER",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":112,"conditions":113,"keywords":126,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":43},"100486132","gene-expression-profiles-in-spinal-tuberculosis-100486132","NCT05610098","Gene Expression Profiles in Spinal Tuberculosis.","Comparing Gene Expression Profiles of Adults With Isolated Spinal TB to Disseminated Spinal TB Identified by 18FDG-PET\u002FCT at Time of Diagnosis, 6-and 12-months Follow-up","SpinalTBX","Inclusion Criteria\n\n1. Participant has completed the written informed consent process prior to undergoing any clinical evaluations and willing to undergo HIV testing\n2. TB spine based on clinical and radiological criteria\n3. Age 18 or older with a body weight of at least 40 kg body weight\n4. Able and willing to return to follow-up\n5. Willing to have samples, including DNA including RNA extraction, stored\n6. Willing to consistently practice a highly reliable method of pregnancy prevention\n\nExclusion Criteria\n\n1. Pregnancy or active desire to become pregnant within the next 6 months.\n2. Uncontrolled diabetes (HbA1c ≥ 6.5% \u002F random glucose concentration ≥11.1 mmol\u002Fl, fasting plasma glucose ≥ 7.0 mmol\u002Fl)\n3. Alcohol and substance abuse which might interfere with medication adherence during the trial\n4. Positive SARS-CoV-2 PCR in the past 4 weeks\n5. Suspicion of malignancy on MRI or known malignancy\n6. Suspicion of inflammatory disease and other rheumatological conditions\n7. Any person for whom the physician feels this study is not appropriate","18 Years",{"count":81,"type":21},"Tuberculosis (TB) is one of the top ten causes of death worldwide with approximately 10 million cases globally and 1.2 million deaths. Sub-Saharan Africa carries the highest burden of TB. South Africa has one of the highest HIV and TB rates worldwide with an HIV prevalence rate in adults of 19% and a TB case notification rate of 615\u002F100,000 in 2019. Over many years, focus has been paid to pulmonary TB and extrapulmonary TB (EPTB) has received only little attention even though it accounts for almost a quatre of all TB cases. The diagnosis of EPTB remains challenging simply because sample collection requires invasive procedures in the absence of a blood-based diagnostic test. Spinal TB (spondylitis or spondylodiscitis caused by Mycobacterium tuberculosis) - often known as Pott's disease - accounts for up to 10% of EPTB and affects young children, people with HIV-coinfection and elderly, and often leads to lifelong debilitating disease due to devastating deformation of the spine and compression of neural structures. Little is known with regards to the extent of disease and isolated TB spine as well as a disseminated form of TB spine have been described. The latter presents with a spinal manifestation plus disseminations to other organs such as the lungs, pleura, lymph nodes, the GIT or urinary tract or even the brain.\n\nIn the Spinal TB X cohort, the investigators aim to describe the clinical phenotype of spinal TB using whole body PET\u002FCT and identify a specific gene expression profile for the different stages of dissemination and compare findings to previously described signatures for latent and active pulmonary TB. A blood-based test for spinal TB would lead to earlier diagnosis and treatment in all settings globally and improve treatment outcome of this devastating disease.",[114,115,58,25,116,117,118,119,120,121,122,123,124,125],"Tuberculosis, Spinal","Tuberculosis, Osteoarticular","Infections","Bone Diseases, Infectious","Musculoskeletal Diseases","Spinal Disease","Spondylitis","Spondylitis; Tuberculosis (Manifestation)","Spondylodiscitis","Positron-Emission Tomography","Diagnostic Imaging","Diagnostic Techniques and Procedures",[127,128,129,130],"Spinal TB","tuberculous spondylodiscitis","FDG-PET\u002FCT","POC","2024-08-22",{"date":133,"type":37},"2024-08-23",{"date":135,"type":37},"2022-10-25",{"date":137,"type":21},"2026-12-31",{"name":139,"class":101},"University of Cape Town",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":149,"conditions":150,"keywords":155,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":43},"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":148,"type":21},40,"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.",[151,152,25,153,154],"Mycobacterium Avium","Mycobacterium Infections, Nontuberculous","Nontuberculous Mycobacterial Lung Disease","Respiratory Tract Diseases",[156,157,158],"Nontuberculous mycobacterium","Whole genome sequencing","Mycobacterium avium","2024-05-17",{"date":161,"type":37},"2024-05-21",{"date":163,"type":37},"2024-05-13",{"date":165,"type":21},"2026-09",{"name":167,"class":101},"University Health Network, Toronto",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":176,"conditions":177,"keywords":181,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":43},"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":81,"type":21},"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).",[178,179,180,25],"Mycobacterium Avium Complex","Mycobacterium Avium-Intracellulare Infection","Gram-Positive Bacterial Infections",[182,183,184,185,186],"Treatment","Minimum Inhibitory Concentration","Drug Concentration","Pharmacokinetics","Pharmacodynamics","2024-01-19",{"date":189,"type":37},"2024-01-22",{"date":191,"type":37},"2023-04-14",{"date":193,"type":21},"2026-10",{"name":195,"class":101},"Shanghai Pulmonary Hospital, Shanghai, China"]