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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
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.
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.
Oregon Health & Science University
Portland, Oregon, United States
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.