[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640399":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":28,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Fondation Ildys","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with cystic fibrosis treated with ETI receiving antibiotic therapy",null,"Patients with cystic fibrosis treated with ETI receiving antibiotic therapy for pulmonary exacerbation",[13],"Other: No intervention assigned",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"No intervention assigned","Routine antibiotic therapy and therapeutic drug monitoring are performed according to standard clinical practice",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Marion Buyse, PharmD, PhD","CONTACT","+33298293447","marion.buyse@ildys.org",{"name":26,"role":22,"phone":10,"phoneExt":10,"email":27},"Matthieu Pichelin","matthieu.pichelin@ildys.org",[29],{"facility":30,"status":31,"city":32,"state":10,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Fondation ILDYS","RECRUITING","Roscoff","29680","France","FR",{"type":37,"coordinates":38},"Point",[39,40],-3.98709,48.72381,{"lat":40,"lon":39},[43],{"name":44,"role":22,"phone":45,"phoneExt":10,"email":24},"Marion Buyse, PharmD; PhD","0298293447",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":58,"type":59},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.",[63,64,65],"Cystic Fibrosis (CF)","Pulmonary Exacerbation","Respiratory Infection Bacterial",[67,68,69,70,71,72,64],"Cystic Fibrosis","CFTR modulators","Elexacaftor\u002FTezacaftor\u002FIvacaftor","Antibiotics","Pharmacokinetics","Therapeutic drug monitoring","2026-06-01",{"date":75,"type":76},"2026-06-05","ACTUAL",{"date":78,"type":76},"2026-03-19",{"date":80,"type":59},"2028-05",{"name":5,"class":6},1]