Recruiting
Phase 2

Cefotetan vs. Standard

Sponsor:

Oregon Health and Science University

Code:

NCT07318584

Conditions

E Coli Infection

ESBL Producing E.Coli

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cefotetan

Carbapenems

Beta Lactam Antibiotics

Study Details

Brief summary:

This pilot study will compare clinical outcomes among patients treated with cefotetan versus standard of care antibiotics for bacteremia caused by E. coli. It will also measure cefotetan minimum inhibitory concentration (MIC) distributions and cefotetan trough serum concentrations.

Conditions

E Coli Infection

ESBL Producing E.Coli

Study ID

NCT07318584

Start date

Jun 26, 2026

Status verified date

Oct, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria (clinical cohort):

  • Identified within 72 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.
  • 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).
  • Any bacteremia with the same organism in the previous 30 days.
  • Pregnant or breastfeeding.
  • Neutropenia (absolute neutrophil count <500 cells/microL), current or anticipated during acute illness.
  • Stem cell transplant or hematologic malignancy receiving chemotherapy.
  • 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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cefotetan

active comparator: Standard of care antibiotics

Interventions

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

Carbapenems

Preferred antibiotic for ESBL E. coli infections: ertapenem. Minimum 1 dose within 24 hours of randomization.

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.

Primary outcome measure

  • Clinical success [ Time Frame: From randomization through 30 days. ]

Central Contacts and Locations

Central contacts

Kristina L. Bajema

503-494-1384bajema@ohsu.edu

James Lewis

503-494-1384lewija@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Kristina L. Bajema

503-494-1384bajema@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • cefotetan
  • cephamycin
  • ESBL producing E. coli
  • E. coli infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.