Cefotetan Therapy for Escherichia Coli Infections

January 2, 2026 updated by: Kristina Bajema, Oregon Health and Science University

Cefotetan Therapy for Escherichia Coli Bacteremia and Genitourinary Infections: a Prospective Phase II Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristina L. Bajema
  • Phone Number: 503-494-1384
  • Email: bajema@ohsu.edu

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • Severe illness, including shock and/or intensive care unit admission.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cefotetan
Drug: Cefotetan
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
Active Comparator: Standard of care antibiotics
Drug: Carbapenems
Preferred antibiotic for ESBL E. coli infections: ertapenem. Minimum 1 dose within 24 hours of randomization.
Other Names:
  • meropenem
  • ertapenem
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization through 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cefotetan MIC
Time Frame: Baseline
Cefotetan MIC from E. coli isolated from blood and/or urine culture
Baseline
Cefotetan trough
Time Frame: Day 1 through 7
Cefotetan serum trough obtained from a subset of participants randomized to cefotetan arm
Day 1 through 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00028869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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