[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-exacerbation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-exacerbation":25},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640399","pharmacokinetics-of-antibiotics-in-patients-with-cystic-fibrosis-trated-with-elexacaftortezacaftorivacaftor-eti-100640399",false,"NCT07629986","Pharmacokinetics of Antibiotics in Patients With Cystic Fibrosis Trated With Elexacaftor\u002FTezacaftor\u002FIvacaftor (ETI)","PKCF","Inclusion Criteria:\n\n* Diagnosis of cystic fibrosis confirmed by sweat test and\u002For genetic testing\n* Treatment with elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI) for at least 3 months\n* Age 12 years or older\n* Patient informed and not objecting to participation; for minors, parents\u002Flegal guardians informed and not objecting to participation\n* Clinical indication for antibiotic therapy for pulmonary exacerbation or respiratory infection according to treating physician\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Lung transplantation or heart-lung transplantation\n* Patients under guardianship or curatorship\n* Pregnant or breastfeeding women","ALL","12 Years",{"count":19,"type":20},30,"ESTIMATED","OBSERVATIONAL","Cystic fibrosis (CF) is associated with major pharmacokinetic and pharmacodynamic alterations affecting antibiotic exposure, including changes in absorption, distribution, metabolism, and elimination. Historically, these alterations justified the use of higher antibiotic doses in CF patients in order to achieve therapeutic concentrations and improve pulmonary outcomes.\n\nThe advent of highly effective CFTR modulators, particularly the triple combination elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI), has substantially improved pulmonary function, nutritional status, inflammatory burden, and quality of life in patients with CF. ETI therapy also appears to modify respiratory microbiology and reduce the frequency of pulmonary exacerbations.\n\nThese clinical and physiological improvements may alter antibiotic pharmacokinetics and pharmacodynamics in patients with CF, potentially making current high-dose antibiotic recommendations less appropriate for some patients. Since repeated exposure to high-dose antibiotics is associated with cumulative toxicities, particularly aminoglycoside-related ototoxicity and nephrotoxicity, reassessment of antibiotic dosing strategies is warranted.\n\nThe PKCF study is a multicenter, prospective, observational, non-interventional study designed to characterize the pharmacokinetic profiles of intravenous antibiotics administered during pulmonary exacerbations in adolescents and adults with cystic fibrosis receiving ETI therapy.",[24,25,26],"Cystic Fibrosis (CF)","Pulmonary Exacerbation","Respiratory Infection Bacterial",[28,29,30,31,32,33,25],"Cystic Fibrosis","CFTR modulators","Elexacaftor\u002FTezacaftor\u002FIvacaftor","Antibiotics","Pharmacokinetics","Therapeutic drug monitoring","RECRUITING","2026-06-01",{"date":37,"type":38},"2026-06-05","ACTUAL",{"date":40,"type":38},"2026-03-19",{"date":42,"type":20},"2028-05",{"name":44,"class":45},"Fondation Ildys","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100587322","ole-therapy-with-be-patients-in-home-care-study-100587322","NCT06926881","OLE Therapy With BE Patients in Home Care Study","Oscillating Lung Expansion (OLE) Therapy in the Bronchiectasis Patients (BE) Home Care Study Protocol","Inclusion Criteria\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Patients aged \\> 5 years old.\n2. History of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention.\n3. Ability to perform BiWaze Clear therapy as prescribed.\n4. Clinically stable respiratory status at the time of screening.\n5. Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).\n6. Signed informed consent (and Child assent if minor subject).\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participating in this study:\n\n1. Diagnosis with rapidly progressing NMD.\n2. Anticipated requirement for hospitalization within the next six months.\n3. History of pneumothorax within the past 6 months.\n4. Use of OLE therapy within the past 12 months.\n5. Inability or unwillingness to perform OLE therapy or study procedures as required.\n6. Currently enrolled in a different study.\n7. Current smoker or tobacco use within the last 30 days.\n8. Pregnancy or Breastfeeding.\n9. Any medical conditions deemed by investigators to have a significant impact on the study results, e.g., active cancer, severe cardiovascular, severe progressive pulmonary disease, liver, kidney, or neurological conditions.\n10. Inability to comply with the treatment protocol or study procedures.\n11. Known allergies to materials used in OLE device.","5 Years",{"count":56,"type":20},85,"INTERVENTIONAL",[59],"NA","The study will examine how the performance of Oscillating Lung Expansion (OLE) therapy affects the respiratory health of patients with Bronchiectasis (BE).\n\nThe patient will use the BiWaze Clear system for their airway clearance therapy, instead of their previously prescribed therapy. BiWaze Clear is an FDA-cleared respiratory therapy for assisting patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high-frequency oscillation therapies, combined with aerosol delivery.\n\nThe patient will perform airway clearance with BiWaze Clear as prescribed. The system uses a disposable breathing circuit, which is a single patient use, disposable circuit.\n\nThe treatment duration is 6 months . The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with an oxygen supply.",[62,25],"Bronchiectasis","2026-04-09",{"date":65,"type":38},"2026-04-14",{"date":67,"type":38},"2025-05-20",{"date":69,"type":20},"2026-08-31",{"name":71,"class":45},"Delve Health",5]