[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mycobacterium-avium-complex\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mycobacterium-avium-complex":28},{"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},"100454016","phase-4-hypertonic-saline-inhalation-for-mycobacterium-avium-complex-pulmonary-disease-100454016",false,"NCT05192057","Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease","A Randomized Controlled Trial on Hypertonic Saline Inhalation in Patients With Nodular-bronchiectatic Mycobacterium Avium Complex Pulmonary Disease","SALINE","Inclusion Criteria:\n\n* International guideline criteria for nodular-bronchiectatic MAC lung disease, i.e. symptomatic, nodular bronchiectatic lesions seen on thorax radiography and ≥2 positive cultures of the same MAC species or one positive culture from a bronchoalveolar lavage;\n* ≥1 positive MAC sputum cultures must be collected in the previous 4 months;\n* Signed and dated patient informed consent.\n\nExclusion Criteria:\n\n* Fibrocavitary MAC lung disease;\n* Antimycobacterial treatment in the last 6 months;\n* Previous MAC lung disease treatment failure, defined as persistent culture positivity despite \\>6 months of guideline-recommended treatment;\n* Current clinical relevant asthma or otherwise bronchial hyperresponsiveness that is judged to be a contra-indication for HSi.\n* Current HSi use\n* Former adverse reaction to HSi (note: former HSi use that was stopped due to a lack of clinical improvement is not an exclusion criterium);\n* Hypertonic saline intolerability during the screening test inhalation\n* Diagnosis of HIV;\n* Diagnosis of Cystic fibrosis (CF);\n* Active pulmonary malignancy (primary or metastatic) or any other malignancy requiring chemotherapy or radiotherapy within 6 months before screening or anticipated during the study period;\n* Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment\n* Current use of chronic systemic corticosteroids at doses of 15 mg\u002Fday for more than 3 months\n* Prior lung or other solid organ transplant\n* Known or suspected current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The SALINE trial will investigate the effect of Hypertonic Saline inhalation plus best supportive care on burden of symptoms, clearance of mycobacteria and functional capacities in participants with Mycobacterium avium complex lung disease and compare the effect to treatment with best supportive care alone.",[27,28],"Nontuberculous Mycobacterial Lung Disease","Mycobacterium Avium Complex","RECRUITING","2025-06-25",{"date":32,"type":33},"2025-06-26","ACTUAL",{"date":35,"type":33},"2022-05-20",{"date":37,"type":21},"2026-10-01",{"name":39,"class":40},"Radboud University Medical Center","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":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"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).",[28,54,55,56],"Mycobacterium Avium-Intracellulare Infection","Gram-Positive Bacterial Infections","Mycobacterium Infections",[58,59,60,61,62],"Treatment","Minimum Inhibitory Concentration","Drug Concentration","Pharmacokinetics","Pharmacodynamics","2024-01-19",{"date":65,"type":33},"2024-01-22",{"date":67,"type":33},"2023-04-14",{"date":69,"type":21},"2026-10",{"name":71,"class":40},"Shanghai Pulmonary Hospital, Shanghai, China"]