[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617435":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":29,"studyPopulation":22,"armGroups":30,"interventions":42,"overallOfficials":22,"centralContacts":58,"locations":67,"responsibleParty":83,"collaborators":22,"id":87,"slug":22,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":22,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":22,"enrollmentInfo":95,"targetDuration":22,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":110,"whyStopped":22,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Oregon Health and Science University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical success","Absence of death, recurrent E. coli, bacteremia, or need for antibiotic treatment for recurrent E.coli genitourinary infection.","From randomization through 30 days.",[14,18],{"measure":15,"description":16,"timeFrame":17},"Cefotetan MIC","Cefotetan MIC from E. coli isolated from blood and\u002For urine culture","Baseline",{"measure":19,"description":20,"timeFrame":21},"Cefotetan trough","Cefotetan serum trough obtained from a subset of participants randomized to cefotetan arm","Day 1 through 7",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE","In this single-center pilot trial, we will study the efficacy of cefotetan versus standard of care antibiotic therapy for patients hospitalized at Oregon Health \\& Science University (OHSU) with bacteremia caused by extended-spectrum β-lactamase-producing (ESBL) and non-ESBL E. coli with a genitourinary source. Participants who consent for enrollment will be randomized 1:1 to receive either cefotetan or standard of care antibiotic therapy for their infection and followed for 30 days to determine clinical outcomes. In addition, we will measure cefotetan MIC distributions among patients with ESBL bloodstream or genitourinary infections. Finally, we will measure cefotetan trough serum concentrations in a subset of enrolled patients with ESBL and non-ESBL E. coli bacteremia who are treated with cefotetan.",[31,36],{"label":32,"type":33,"description":22,"interventionNames":34},"Cefotetan","EXPERIMENTAL",[35],"Drug: Cefotetan",{"label":37,"type":38,"description":22,"interventionNames":39},"Standard of care antibiotics","ACTIVE_COMPARATOR",[40,41],"Drug: Carbapenems","Drug: Beta Lactam Antibiotics",[43,47,54],{"type":44,"name":32,"description":45,"armGroupLabels":46,"otherNames":22},"DRUG","Minimum 1 dose cefotetan within 24 hours of randomization. Creatinine clearance (CrCl) \\>30 mL\u002Fminute: 2 g IV every 12 hours; CrCl 10-30 mL\u002Fminute: 2 g IV every 24 hours; CrCl \\\u003C10 mL\u002Fminute: 2 g IV every 48 hours",[32],{"type":44,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Carbapenems","Preferred antibiotic for ESBL E. coli infections: ertapenem. Minimum 1 dose within 24 hours of randomization.",[37],[52,53],"ertapenem","meropenem",{"type":44,"name":55,"description":56,"armGroupLabels":57,"otherNames":22},"Beta Lactam Antibiotics","Beta lactam antibiotics for non-ESBL E. coli infections include preferred ceftriaxone or alternative cephalosporins (cefepime, ceftazidime), penicillins (piperacillin-tazobactam, ampicillin-sulbactam), and carbapenems (ertapenem, meropenem). Minimum 1 dose within 24 hours of randomization.",[37],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":22,"email":63},"Kristina L. Bajema","CONTACT","503-494-1384","bajema@ohsu.edu",{"name":65,"role":61,"phone":62,"phoneExt":22,"email":66},"James Lewis","lewija@ohsu.edu",[68],{"facility":69,"status":22,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Oregon Health & Science University","Portland","Oregon","97239","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-122.67621,45.52345,{"lat":79,"lon":78},[82],{"name":60,"role":61,"phone":62,"phoneExt":22,"email":63},{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Kristina Bajema","Assistant Professor of Medicine","100617435",false,"NCT07318584","Cefotetan Therapy for Escherichia Coli Infections","Cefotetan Therapy for Escherichia Coli Bacteremia and Genitourinary Infections: a Prospective Phase II Pilot Study","Inclusion Criteria (clinical cohort):\n\n* Identified within 48 hours of inpatient antibiotic administration for acute illness.\n* Patient or legally authorized representative are able to provide informed consent for participation in the study.\n* Monomicrobial E. coli bacteremia with a genitourinary source.\n* Isolate susceptible to both ertapenem and cefotetan (ESBL infections) or ceftriaxone and cefotetan (non-ESBL infections).\n\nExclusion Criteria (clinical cohort):\n\n* Allergy to cefotetan.\n* History of cephalosporin-associated hemolytic anemia.\n* Allergy to ertapenem or meropenem (among patients with ESBL E. coli infections).\n* Allergy to ceftriaxone (among patients with non-ESBL E. coli infections). Includes allergy to antibiotics with a similar structure expected to confer cross reactivity to ceftriaxone (cefotaxime, cefpodoxime, ceftazidime).\n* Admission within 30 previous days.\n* Any bacteremia with the same organism in the previous 90 days.\n* Pregnant or breastfeeding.\n* Moderately to severely immunocompromised, including solid organ or stem cell transplant, hematologic malignancy, active chemotherapy.\n* Admission with neutropenic fever.\n* Severe illness, including shock and\u002For intensive care unit admission.\n* Inability to complete at least 72 hours of appropriate parenteral therapy, including at least 1 dose cefotetan for patients randomized to the treatment arm or at least 1 dose of appropriate parenteral therapy following randomization for patients assigned to the standard of care arm.","ALL","18 Years",{"count":96,"type":97},84,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","This pilot study will compare clinical outcomes among patients treated with cefotetan versus standard of care antibiotics for bacteremia or genitourinary infections caused by E. coli. It will also measure cefotetan minimum inhibitory concentration (MIC) distributions and cefotetan trough serum concentrations.",[103,104],"E Coli Infection","ESBL Producing E.Coli",[106,107,108,109],"cefotetan","cephamycin","ESBL producing E. coli","E. coli infection","NOT_YET_RECRUITING","2026-01-02",{"date":113,"type":114},"2026-01-06","ACTUAL",{"date":116,"type":97},"2026-03",{"date":118,"type":97},"2028-08",{"name":5,"class":6},1]