[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mycobacterium-abscessus-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mycobacterium-abscessus-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,78,101],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100616108","phase-2-epetraborole-in-patients-with-mycobacterium-abscessus-lung-disease-100616108",false,"NCT07301320","Epetraborole in Patients With Mycobacterium Abscessus Lung Disease","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Prospective, Investigator-Initiated Trial to Assess the Efficacy, Safety, and Pharmacokinetics of Epetraborole in Patients With Mycobacterium Abscessus Lung Disease: REBOUND Study","REBOUND","Inclusion Criteria:\n\n1. Male or female patients who are 18 years of age or older.\n2. Willing and able to provide written informed consent.\n3. Patients with MABc lung disease, meeting the following (a) Microbiological, (b) Clinical, (c) Radiographic\n\n   a. Microbiological criteria: i. Documentation of at least 1 Pre-Study MABc-positive respiratory specimen (sputum or deep bronchial specimen) collected per standard of care within 6 months prior to signing the consent form.\n\n   ii. At least 1 Screening MABc-positive expectorated or induced sputum sample. b. Clinical criteria: At least 2 of the following patient-reported clinical symptoms: i. Chest pain ii. Chronic cough iii. Coughing up blood iv. Fatigue v. Fever (documented by thermometer) vi. Mucus (sputum) production vii. Night sweats (drenching perspiration with no other obvious etiology, e.g. perimenopausal) viii. Poor appetite ix. Shortness of breath x. Weight loss (unintentional, more than 5% of usual weight in 6 to 12 months) c. Radiographic criteria: Non-contrast chest CT scan within 4 months prior to signing the ICF (Pre-Study chest CT) or within the Screening Period (Screening chest CT) with abnormalities consistent with MABc-LD based on local interpretation (e.g. Investigator or local radiologist).\n4. Patients who, in the opinion of the investigator, will not require initiation of guideline-directed antibiotic therapy for treatment of MABc-LD within the next 6 months, and for whom a delay, in order for the subject to participate in a placebo-controlled clinical trial, is considered both reasonable and clinically acceptable.\n5. Patients who are willing to comply with all the study activities and procedures throughout the duration of the study.\n\n   1. Patients must agree to use an effective method of birth control, if applicable, as follows: Females of childbearing potential (FOCPs; defined in Appendix 1, Contraception Requirements) must commit to either sexual abstinence or use of at least 2 medically accepted, effective methods of birth control (defined in Contraception Requirements) from Screening through the EOS Visit\n   2. Males who are sexually active with a FOCP must agree to use an effective barrier method of contraception (defined in Contraception Requirements) from Screening through the EOS Visit\n6. Patients expected to survive with continued antimycobacterial therapy and appropriate supportive care from Screening through the LFU Visit, in the judgment of the Investigator.\n\nExclusion Criteria:\n\n1. Patients with a presence of any suspected or confirmed disease or condition at Screening or the time of randomization that, in the opinion of the Investigator, may confound the assessment of symptom-based clinical response, including, but not limited to, the following:\n\n   * Radiographic presence of cavitary disease (defined as a patient with one or more cavities \\>2 cm internal diameter)\n   * Cystic fibrosis or other inherited disorders of airway ciliary dysfunction (e.g., primary ciliary dyskinesia)\n   * Active allergic bronchopulmonary mycosis\n   * Anticipated or planned lung surgery for treatment of MABc lung disease\n   * Disseminated MABc infection, or other known or suspected non-pulmonary source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, or urinary tract infection) requiring non-study antimicrobial therapy\n   * Concomitant pulmonary infection requiring antimicrobial therapy, including infection caused by fungi, viruses, non-MABc mycobacteria (e.g., Mycobacterium tuberculosis, Mycobacterium avium intracellulare, Mycobacterium avium complex, Mycobacterium kansasii), or other bacteria (e.g., Pseudomonas aeruginosa, Staphylococcus aureus).\n\n   Note: Patients with MABc lung disease and concomitant non-MABc lung infection requiring antimicrobial therapy must complete the antimicrobial treatment for the non-MABc infection prior to randomization. Patients with respiratory specimen cultures that contain growth of non-MABc organisms that are deemed by the Investigator to be respiratory tract colonizers and who do not require or receive specific antimicrobial therapy may remain eligible. The Investigator should discuss such cases with the Study Investigator prior to randomization and provide rationale for study eligibility in the source document.\n2. Patients on brensocatib who have not been on a stable dose for at least 12 weeks.\n3. Patients with active pulmonary malignancy (primary or metastatic) or any malignancy that required or would require chemotherapy or radiation therapy within 1 year prior to randomization through the LFU Visit.\n4. Patients with creatinine clearance (CrCl) of \\\u003C30 mL\u002Fmin, as estimated by the Cockcroft-Gault formula, at Screening: Estimated CrCl (mL\u002Fmin) = (140 - Age \\[years\\]) × Actual Body Weight \\[kg\\] × \\[0.85 if Female\\]) \u002F (72 × Serum Creatinine \\[mg\u002FdL\\]).\n5. Patients with any of the following hematological findings:\n\n   1. Hemoglobin \\\u003C11.0 g\u002FdL or \\\u003C6.83 mmol\u002FL.\n   2. Donation of blood or plasma within 28 days prior to randomization; or symptomatic loss of blood or hemorrhage within 28 days prior to randomization.\n   3. Pre-existing (inborn or acquired) disorder of hematopoiesis that could substantially worsen the effect of EBO on hemoglobin levels or potentially prevent hemoglobin recovery post cessation of treatment, for example, thalassemia, sickle cell disease, hemolytic anemia, Inherited bone marrow failure syndromes, myelodysplastic or myeloproliferative disorders, bone marrow transplantation\n6. Patients with severe hemoptysis within 28 days prior to randomization, defined as \\>100 mL (approximately \\>7 tbsp blood) over any 24-hour period.\n7. Patients with severe hepatic impairment, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 × upper limit of normal (ULN) or total bilirubin \\>2 × ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).\n8. Patients who are pregnant or breastfeeding.\n9. Patients with a mean QT interval corrected using Fridericia's formula (QTcF) \\>500 msec based 12-lead ECG at Screening.\n10. Patients with an immunodeficiency or an immunocompromised condition and risk for an opportunistic pulmonary infection, including:\n\n    * History of lung transplantation\n    * Known history of human immunodeficiency virus (HIV) infection plus either an active acquired immunodeficiency syndrome (AIDS)-defining illness in the past 12 months, or a known cluster of differentiation 4 (CD4) count \\\u003C200\u002Fmm3 within the past 12 months\n    * Neutropenia at Screening (absolute neutrophil count \\\u003C1,000 neutrophils\u002Fmm3)\n    * Use of immunosuppressive therapy at Screening that in the opinion of the Investigator may place the patient at risk for an opportunistic pulmonary infection, including transplant rejection medication and chronic systemic corticosteroids defined as ≥15 mg\u002Fday of prednisone or systemic equivalent for \\>4 weeks.\n11. Patients with an anticipated start of new non-study antimycobacterial therapy to be administered at any time between Screening and EOT.\n12. Patients who have participated in a clinical trial of an investigational agent within 30 days (or 5 half-lives, whichever is longer) prior to Screening.\n13. Patients with any prior exposure to epetraborole.\n14. Patients with any condition that, in the opinion of the Investigator, interferes with the ability to safely complete the study or adhere to study requirements, including the patient's inability or unwillingness to comply with all study assessments and visits.\n15. Patients with hypersensitivity to any EBO excipient (e.g., microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc).\n16. Patients with a history of eosinophilic interstitial pneumonitis\n\nFor eligibility purposes, vital signs, clinical laboratory tests, and ECGs may be repeated once if an abnormal result is observed at the initial reading during Screening.","ALL","18 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus complex (MABc) Lung Disease (LD) of mild to moderate severity. For this study, two EBO oral dose regimens will be studied in patients with MABc-LD, each compared to a placebo group (ie, 4 treatment groups): 500 mg daily and 750 mg daily. Detailed inclusion and exclusion criteria attempt to identify only those patients who have acceptable risks based upon the EBO preclinical findings, phase 1, phase 2, and Phase 3 experience; standard-of-care procedures; and the specified procedures of the study. Following receipt of informed consent, and a Screening period, eligible patients will be randomized to one of the 4 treatment groups to receive active or matched placebo EBO tablets for 84 days. Patients will be assessed for clinical and microbiological evidence of efficacy. At selected investigative sites, patients will undergo sparse PK sampling. Safety and tolerability will be determined by standard clinical and laboratory assessment, with oversight by a qualified and appropriately constituted Data Safety Monitoring Board (DSMB). Data collected during the study will be analyzed per a comprehensive Statistical Analysis Plan (SAP). The study will be registered on clinicaltrials.gov. The total duration of patient participation is approximately 6 months.",[27],"Mycobacterium Abscessus Infection",[29,30,31,32,33],"NTM","nontuberculous mycobacteria","Mycobacterium abscessus","M. abscessus","abscessus","RECRUITING","2026-05-05",{"date":37,"type":38},"2026-05-06","ACTUAL",{"date":40,"type":38},"2026-03-30",{"date":42,"type":21},"2028-05",{"name":44,"class":45},"Kevin Winthrop","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"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":57,"type":21},300,[24],"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.",[61,27,62,63],"Mycobacterium Abscessus Pulmonary Disease","Non-Tuberculous Mycobacterial (NTM) Infections","Non-Tuberculous Mycobacteria Pulmonary Disease",[65,66,67],"adaptive platform trial","dual beta lactam","sulbactam-durlobactam","NOT_YET_RECRUITING","2026-03-16",{"date":71,"type":38},"2026-03-20",{"date":73,"type":21},"2027-04",{"date":75,"type":21},"2031-07",{"name":77,"class":45},"The University of Queensland",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100625940","phase-1-bacteriophage-for-chronic-multidrug-resistant-mycobacterium-abscessus-subsp-abscessus-pulmonary-infection-100625940","NCT07429162","Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection","DP-QB-MYA-002 Phage Cocktail for Chronic Multidrug-Resistant (MDR) Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection","Inclusion Criteria:\n\n* Consent to participation\n\nExclusion Criteria:\n\n* non-consent to participation",{"count":46,"type":21},[87],"PHASE1","The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.",[27,90,91],"Bacteriophage Therapy","Pulmonary Disease","2026-02-17",{"date":94,"type":38},"2026-02-24",{"date":96,"type":21},"2026-07-02",{"date":98,"type":21},"2028-07-02",{"name":100,"class":45},"Alberta Health services",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100621345","environmental-reservoirs-of-non-tuberculous-mycobacteria-in-cystic-fibrosis-households-a-case-control-study-of-exposure-risk-at-home-100621345","NCT07369414","Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home","NTMecoCF","Inclusion Criteria:\n\n* Confirmed diagnosis of cystic fibrosis (CF)\n* No age restriction (including minors with consent from legal guardians)\n* Written informed consent to participate in the study (or consent provided by a legal guardian for minors)\n* In the case of an NTM infection: diagnosis according to ATS\u002FIDSA criteria and availability of a clinical NTM isolate\n\nExclusion Criteria:\n\n* Lack of capacity to provide informed consent, refusal to participate, or withdrawal of informed consent",{"count":109,"type":21},120,"OBSERVATIONAL","This multicenter, non-interventional case-control study investigates whether household environmental reservoirs, particularly water systems, are associated with non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis. Environmental samples from the homes of CF patients with and without NTM infection will be analyzed and genetically compared with available clinical isolates, alongside assessment of environmental risk factors, to improve understanding of exposure pathways and inform future prevention strategies.",[113,114,115,27],"Cystic Fibrosis (CF)","Mucoviscidosis","Non-Tuberculous Mycobacteria",[117,118,119,120,121],"Environmental reservoirs","Household water systems","Microbial exposure","Whole-genome sequencing","Environmental risk factors","2026-01-16",{"date":124,"type":38},"2026-01-27",{"date":126,"type":21},"2026-01",{"date":128,"type":21},"2030-12",{"name":130,"class":45},"Research Center Borstel",2]