A Phase 2 interventional study of Cefotetan and Carbapenems in E Coli Infection and ESBL Producing E.Coli, sponsored by Oregon Health and Science University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Oregon Health and Science University · Phase 2, Interventional, and Treatment
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.
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.
96 studies on the registry are indexed under Escherichia coli Infections; 17 are open to participants now.
This study's planned enrollment of 84 is close to the median of 90 across 58 interventional studies indexed under Escherichia coli Infections.
Browse Escherichia coli Infections studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria (clinical cohort):
Drug: Cefotetan
Drug: Carbapenems · Drug: Beta Lactam Antibiotics
Minimum 1 dose cefotetan within 24 hours of randomization. Creatinine clearance (CrCl) \>30 mL/minute: 2 g IV every 12 hours; CrCl 10-30 mL/minute: 2 g IV every 24 hours; CrCl \<10 mL/minute: 2 g IV every 48 hours
Preferred antibiotic for ESBL E. coli infections: ertapenem. Minimum 1 dose within 24 hours of randomization.
Also known as: ertapenem, meropenem
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.
Clinical success
Absence of death, recurrent E. coli, bacteremia, or need for antibiotic treatment for recurrent E.coli genitourinary infection.
Time frame: From randomization through 30 days.
Cefotetan MIC
Cefotetan MIC from E. coli isolated from blood and/or urine culture
Time frame: Baseline
Cefotetan trough
Cefotetan serum trough obtained from a subset of participants randomized to cefotetan arm
Time frame: Day 1 through 7
Plan to share: No
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University