[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kevin Winthrop\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100495369","phase-2-prevention-of-ototoxicity-in-ntm-patients-treated-with-iv-amikacin-100495369","NCT05730283","Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin","Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin Therapy for Non-Tuberculous Mycobacterium Disease","Inclusion Criteria:\n\n1. Providing informed consent, documented by signing and dating the currently valid informed consent form.\n2. Considered by the Investigator to have unimpaired consent capacity, without reliance on a legally authorized representative.\n3. Stated willingness and ability to comply with study procedures and availability for the duration of the study.\n4. Aged \\> 18 and \\\u003C 80.\n5. NTM infection meeting current Pulmonary NTM guidelines from the American Thoracic Society and the Infectious Diseases Society of America (ATS\u002FIDSA) for systemic (IV) aminoglycoside therapy.\n6. Anticipated duration of IV amikacin treatment of at least 30 days at time of study entry.\n7. Statement of ability to take oral medication and adhere to the daily dosing regimen.\n8. For females of reproductive potential: If they are of childbearing potential, they must agree in writing to practice an effective double barrier method of contraception from the signing of the informed consent form until 1 month following discontinuation of study drug treatment or agree to practice true abstinence, when this is consistent with the preferred and usual lifestyle of the subject.\n9. For males of reproductive potential: Agree to practice effective barrier contraception from the signing of the informed consent form until 3 months (one spermatogenesis cycle) following the last dose of study drug or agree to practice true abstinence.\n\nExclusion Criteria:\n\n1. Received a systemic aminoglycoside antibiotic within 6 months prior to planned first dose of amikacin.\n2. ECG at Screening or prior to randomization (mean of triplicate values) with QT interval corrected using Fridericia's formula (QTcF interval) ≥ 450 msec.\n3. ECG at Screening or prior to randomization with abnormalities that, in the Investigator's judgment, might predispose patient to clinically significant arrhythmia.\n4. Patients taking strong CYP3A4 inducers such as rifampin and rifabutin in the 7 days prior to randomization or have the need for ongoing treatment with concomitant oral or intravenous therapy with strong CYP3A4 inducers during the study. If an additional antibiotic is needed, then azithromycin will be used.\n5. Patients taking strong CYP3A4 inhibitors such as clarithromycin in the 7 days prior to randomization or the need for ongoing treatment with concomitant oral or intravenous therapy with strong CYP3A4 inhibitors during the study. If an additional antibiotic is needed, then azithromycin will be used.\n6. Patients taking clofazimine or bedaquiline AND who also have congestive heart failure, significant ventricular arrhythmia, uncorrected hypokalemia, or ECG (single at Screening, mean of triplicate prior to randomization) showing QRS \\> 120 msec or heart rate \\\u003C 50 bpm.\n7. Patients with amikacin exposure within the 6 months prior to randomization.\n8. Patients with known amikacin resistance (MIC \\>64)\n9. Progressive liver disease (Child-Pugh B or C) which would affect or invalidate interpretation of change from the baseline liver function tests over the course of the study.\n10. Signs of disturbed integrity of the tympanic membrane, determined by otoscopy or tympanometry, including chronic perforation or middle ear or ear canal inflammation or effusion.\n11. History of congenital hearing loss, otological surgery (excluding myringotomy tubes or simple tympanoplasty healed and currently intact), sudden hearing loss, or Meniere's disease.\n12. Bilateral profound hearing loss (\\>90 Decibels \\[dB\\] HL) at all test frequencies.\n13. Conductive hearing loss evidenced by average air-bone-gaps \\>15 dB HL for 0.25-4.0 kilohertz (kHz)\n14. History of active malignancy, either untreated or under active treatment.\n15. History of risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n16. Venous access not adequate for performance of study procedures.\n17. Presence of any circumstance, condition, ECG or laboratory finding that, based on investigator judgment, would interfere with study procedures or assessments or present to the patient an unreasonable risk from participation in this study.\n18. Current or anticipated use of excluded concomitant medications as specified in Section 6.5.\n19. Pregnant or lactating.\n20. Female of childbearing potential who does not have a negative serum pregnancy test and does not agree in writing to using a double barrier method of contraception.\n21. Female relying on menopausal status for contraception who does not have Follicle-Stimulating Hormone (FSH) level consistent with that condition and who does not agree in writing to using a double barrier method of contraception.\n22. Currently under correctional supervision (imprisoned, on probation or parole).","80 Years",{"count":56,"type":21},105,[24],"The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy. The main question this study aims to answer is:\n\n* Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment?\n* Is ORC-13661 effective for preventing or lessening other measures of hearing impairment?\n\nParticipants will be asked to take a study drug while they are being treated with IV amikacin. Participants will take study drug for 90 days or until the end of their amikacin treatment, whichever comes first. During this time, researchers will gather clinical data on the participants' health.\n\nResearchers will compare three groups - two groups taking different doses of the study drug and one group taking a placebo drug - to see if dose of drug has any effect on preventing hearing loss. A placebo is a look-alike substance that contains no active drug.",[60],"Ototoxicity, Drug-Induced",[29,30,62,63],"ototoxicity","hearing loss",{"date":65,"type":38},"2026-05-07",{"date":67,"type":38},"2025-06-02",{"date":69,"type":21},"2028-02-29",{"name":44,"class":45},7,""]