Cefotetan Therapy for Escherichia Coli Bacteremia and Genitourinary Infections: a Prospective Phase II Pilot Study
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Clinical success
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(clinical cohort):
- •Identified within 48 hours of inpatient antibiotic administration for acute illness.
- •Patient or legally authorized representative are able to provide informed consent for participation in the study.
- •Monomicrobial E. coli bacteremia with a genitourinary source.
- •Isolate susceptible to both ertapenem and cefotetan (ESBL infections) or ceftriaxone and cefotetan (non-ESBL infections).
Exclusion Criteria
- •(clinical cohort):
- •Allergy to cefotetan.
- •History of cephalosporin-associated hemolytic anemia.
- •Allergy to ertapenem or meropenem (among patients with ESBL E. coli infections).
- •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).
- •Admission within 30 previous days.
- •Any bacteremia with the same organism in the previous 90 days.
- •Pregnant or breastfeeding.
- •Moderately to severely immunocompromised, including solid organ or stem cell transplant, hematologic malignancy, active chemotherapy.
- •Admission with neutropenic fever.
Arms & Interventions
Cefotetan
Intervention: Cefotetan (Drug)
Standard of care antibiotics
Intervention: Carbapenems (Drug)
Standard of care antibiotics
Intervention: Beta Lactam Antibiotics (Drug)
Outcomes
Primary Outcomes
Clinical success
Time Frame: From randomization through 30 days.
Absence of death, recurrent E. coli, bacteremia, or need for antibiotic treatment for recurrent E.coli genitourinary infection.
Secondary Outcomes
- Cefotetan MIC(Baseline)
- Cefotetan trough(Day 1 through 7)
Investigators
Kristina Bajema
Assistant Professor of Medicine
Oregon Health and Science University