[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acinetobacter-pneumonia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acinetobacter-pneumonia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":20,"type":21},734,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Carbapenem Resistant Bacterial Infection","Acinetobacter Bacteremia","Acinetobacter Pneumonia","RECRUITING","2025-07-29",{"date":33,"type":34},"2025-08-01","ACTUAL",{"date":36,"type":34},"2024-09-01",{"date":38,"type":21},"2026-09",{"name":40,"class":41},"Rambam Health Care Campus","OTHER",3]