[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-tuberculous-mycobacterial-ntm-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-tuberculous-mycobacterial-ntm-infections":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,65],{"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":4,"enrollmentInfo":4,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":62,"locationsCount":4},"100388153","lamprene-multiple-patient-program-100388153","NCT04334070","Lamprene Multiple Patient Program","Novartis Multiple Patient Program for Lamprene® (Clofazimine) for the Treatment of Non-Tuberculous Mycobacterial (NTM) Infections","Inclusion Criteria:\n\n1. Male or female patients 18 years of age or older\n2. Written informed consent must be obtained before any project specific assessment is performed.\n3. Patients previously diagnosed with NTM infection with local or disseminated infection(i.e. patients with any NTM species at any site of infection)\n4. Patients who failed or are intolerant of prior therapies or who have baseline macrolide resistance or for whom an appropriate regimen cannot otherwise be devised\n5. Male patients (including vasectomized patients) who agree to use a condom during intercourse while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine\n6. Female patients of child-bearing potential with negative pregnancy test before clofazimine treatment initiation and who confirm no intention to become pregnant during the treatment with clofazimine, by using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine\n2. History or current diagnosis of clinically significant ECG abnormalities that pose a safety risk for the patient, such as clinically significant cardiac arrhythmias (e.g.,sustained ventricular tachycardia, second or third degree heart block without a pacemaker)\n3. History or additional risk factors for Torsades de Pointes such as heart failure, clinically relevant hypokalemia, familial long QT syndrome or known family history of Torsades de Pointes\n4. Confirmed demonstration of resting QTcF \\>500 msec at screening\n5. Any condition (social, psychiatric, or medical) which in the opinion of the treating physician would make participation in this MPP unsafe\n6. Unable to swallow capsules\n7. HIV-infected patients with disseminated NTM infection\n8. Life expectancy less than 6 months\n9. Pregnant or nursing (lactating) females","18 Years","EXPANDED_ACCESS","Lamprene®\u002FClofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®\u002FClofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).\n\nTo be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®\u002FClofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.",[29],"AVAILABLE","2025-12-01",{"date":61,"type":39},"2025-12-05",{"name":63,"class":64},"Novartis Pharmaceuticals","INDUSTRY",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":5},"100603073","treatment-monitoring-for-ntm-infections-with-a-symptom-diary-100603073","NCT07131774","Treatment Monitoring for NTM Infections With a Symptom Diary","Evaluation of a Diary for Assessing Treatment Outcomes in Patients With Pulmonary Infections Caused by Nontuberculous Mycobacteria (NTM)","NTMdiary","Inclusion Criteria:\n\n* Pulmonary NTM infection according to ATS\u002FIDSA criteria (1)\n* Age ≥ 18 years\n* Ability to provide informed consent\n* Willingness to participate in the study AND\n* Clinical decision to initiate antimicrobial therapy as part of routine care\n\n  * Cohort 1 OR\n* Clinical decision against antimicrobial therapy as part of routine care\n\n  * Cohort 2\n\nExclusion Criteria:\n\n* Lack of ability to provide informed consent\n* Language barriers that prevent completion of the diary\n* Antimicrobial therapy for the NTM infection already initiated",{"count":74,"type":21},200,"OBSERVATIONAL","The primary aim of the study is to investigate the correlation between patient-reported symptoms recorded in the diary and the microbiological and radiological disease course in patients with pulmonary infections caused by nontuberculous mycobacteria (NTM).",[29],[79,80,81],"symptom diary","microbiology","radiology","RECRUITING","2025-08-12",{"date":85,"type":39},"2025-08-20",{"date":87,"type":39},"2025-07-11",{"date":89,"type":21},"2026-06",{"name":91,"class":46},"Research Center Borstel"]