[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510106":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":45,"centralContacts":55,"locations":62,"responsibleParty":103,"collaborators":105,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":40,"enrollmentInfo":126,"targetDuration":40,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":40,"overallStatus":64,"whyStopped":40,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Rambam Health Care Campus","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cefiderocol + ampicillin-sulbactam","EXPERIMENTAL","Cefiderocol 2 gram intravenous (IV) q8 hours and ampicillin-sulbactam 3 gram IV q6 hours for patients with normal creatinine clearance, both administered as extended infusion of 3 hours. Dosing adjusted according to reduced and augmented renal clearance and to renal replacement therapies.",[13,14],"Drug: Cefiderocol","Drug: Ampicillin-sulbactam",{"label":16,"type":17,"description":18,"interventionNames":19},"Colistin or colistin + meropenem","ACTIVE_COMPARATOR","Colistin 9 million units (MIU) intravenous (IV) loading dose followed by 4.5 MIU for patients with normal creatinine clearance +\u002F- meropenem 2 gram IV administered as extended infusion of 3 hours. Dosing adjusted according to reduced and augmented renal clearance and to renal replacement therapies.",[20,21],"Drug: Colistin","Drug: Meropenem",[23,30,36,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Cefiderocol","Test drug regimen",[9],[29],"Fetroja",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Ampicillin-sulbactam","Synergistic combination",[9],[35],"Unasyn",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Colistin","Historical comparator",[16],null,{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"Meropenem","Historical comparator synergistic combination",[16],[46,50,53],{"name":47,"affiliation":48,"role":49},"Marco Falcone","Pisa University Hospital","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":52,"role":49},"Dafna Yahav","Sheba Medical Center",{"name":54,"affiliation":5,"role":49},"Mical Paul",[56,60],{"name":54,"role":57,"phone":58,"phoneExt":40,"email":59},"CONTACT","0502062140","paulm@technion.ac.il",{"name":47,"role":57,"phone":40,"phoneExt":40,"email":61},"marco.falcone@unipi.it",[63,79,92],{"facility":5,"status":64,"city":65,"state":40,"zip":40,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Haifa","Israel","IL",{"type":69,"coordinates":70},"Point",[71,72],34.99928,32.81303,{"lat":72,"lon":71},[75,78],{"name":76,"role":57,"phone":40,"phoneExt":40,"email":77},"Mical Paul, MD","m_paul@rambam.health.gov.il",{"name":76,"role":49,"phone":40,"phoneExt":40,"email":40},{"facility":80,"status":64,"city":81,"state":40,"zip":40,"country":66,"countryCode":67,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Sheba Tel HaShomer Medical Campus","Ramat Gan",{"type":69,"coordinates":83},[84,85],34.81065,32.08227,{"lat":85,"lon":84},[88,90],{"name":89,"role":57,"phone":40,"phoneExt":40,"email":40},"Dafna Dahav, MD",{"name":91,"role":49,"phone":40,"phoneExt":40,"email":40},"Dafna Yahav, MD",{"facility":93,"status":64,"city":94,"state":40,"zip":40,"country":66,"countryCode":67,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Shamir Medical Center (Assaf Harofeh)","Tel Aviv",{"type":69,"coordinates":96},[97,98],34.78057,32.08088,{"lat":98,"lon":97},[101],{"name":102,"role":57,"phone":40,"phoneExt":40,"email":40},"Dror Marchaim",{"type":104,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[106,108,110,112,115],{"name":107,"class":6},"Monaldi Hospital",{"name":109,"class":6},"Rutgers Robert Wood Johnson Medical School",{"name":48,"class":111},"UNKNOWN",{"name":113,"class":114},"Assaf-Harofeh Medical Center","OTHER_GOV",{"name":52,"class":114},"100510106","phase-4-cefiderocol-and-ampicillin-sulbactam-vs-colistin---meropenem-for-carbapenem-resistant-a-baumannii-100510106",false,"NCT05922124","Cefiderocol and Ampicillin-sulbactam vs. Colistin +\u002F- Meropenem for Carbapenem Resistant A. Baumannii","Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)","CASCADE","Inclusion Criteria:\n\nAdults \\>18 years with bacteremia or hospital-acquired pneumonia (HAP)\u002F ventilator-associated pneumonia (VAP) (Table 3) caused by carbapenem-resistant A. baumannii (CRAB) (meropenem and\u002F or imipenem minimal inhibitory concentration (MIC) \\>8 μg\u002FmL) susceptible to cefiderocol (disc zone diameter \\>=17 mm, corresponding to an MIC \\\u003C2 μg\u002FmL). We will include CRAB regardless of colistin, ampicillin-sulbactam, minocycline, tigecycline, trimethoprim\u002Fsulfamethoxazole and\u002For aminoglycoside susceptibility of the isolate. Attribution of the HAP\u002F VAP to CRAB will be allowed with isolation of CRAB from any respiratory sample within 7 days prior to the clinical diagnosis of pneumonia.\n\nExclusion Criteria:\n\n* More than 72 hours of therapy with in-vitro coverage against the CRAB within 96 hours of enrolment\n* Polymicrobial carbapenem-susceptible infections: growth of other pathogens susceptible to carbapenems, or another beta-lactam, deemed clinically-significant by the treating physicians in blood or sputum (with HAP\u002F VAP). We will allow recruitment of patients with other carbapenem-resistant Gram-negative bacteria\n* CRAB susceptible any beta-lactam other than cefiderocol\n* Coronavirus 2019 (COVID-19) co-infection\n* Immediate-type hypersensitivity to penicillin\n* Pregnant women\n* Previous participation in the trial\n* Lack of informed consent, considering the procedures acceptable to ethics committees per locale, including deferred consent\n* Infection requiring treatment for over 14 days, at the discretion of the investigators\n* Life expectancy less than 24 hours or expected futility of antibiotic treatment","ALL","16 Years",{"count":127,"type":128},734,"ESTIMATED","INTERVENTIONAL",[131],"PHASE4","Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.",[134,135,136],"Carbapenem Resistant Bacterial Infection","Acinetobacter Bacteremia","Acinetobacter Pneumonia","2025-07-29",{"date":139,"type":140},"2025-08-01","ACTUAL",{"date":142,"type":140},"2024-09-01",{"date":144,"type":128},"2026-09",{"name":5,"class":6},3]