Cefotetan Therapy for E. coli Infections
Official title: Cefotetan Therapy for Escherichia Coli Infections: a Prospective Phase II Pilot Study
Run by Oregon Health and Science University · NCT07318584 · Data updated 2026-11-12
This pilot study tests whether cefotetan works for bloodstream infections caused by E. coli, compared with standard antibiotics, to see if it improves outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | June 26, 2026 |
| Main results expected | October 2028 |
| Study ends | April 2029 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07318584 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults hospitalized with monomicrobial E. coli bacteremia (ESBL or non-ESBL) who are able to consent and have isolates susceptible to cefotetan and comparator drugs.
✕Probably not a fit
Patients with cefotetan allergy, certain antibiotic allergies, recent bacteremia with the same organism, pregnancy, or severe neutropenia may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a single-center, randomized pilot trial at OHSU, adults with E. coli bacteremia will be assigned 1:1 to receive cefotetan or a standard-of-care antibiotic. The study will track clinical outcomes over 30 days and also measure cefotetan MIC distributions and trough serum concentrations in a subset. Participants will be enrolled within 72 hours of starting inpatient antibiotics and must have monomicrobial E. coli bacteremia with susceptibility patterns allowing cefotetan use. Safety considerations include exclusion of individuals with cefotetan allergy, cephalosporin-associated hemolytic anemia, or other antibiotic allergies that could confound results.
Why it matters
Potential benefit: If cefotetan is effective, patients could experience similar or better outcomes with an alternative to current standard therapies.
How similar studies have gone: Prior work in ESBL and non-ESBL E. coli infections has explored alternative cephalosporin and beta-lactam strategies, but this exact cefotetan versus standard therapy approach is relatively novel in bacteremia.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Oregon Health & Science University
Portland, Oregon, United States Recruiting
Study contacts
- Study coordinator: Kristina L. Bajema
- Email: bajema@ohsu.edu
- Phone: 503-494-1384
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Topical ruxolitinib for adults with pyoderma gangrenosum
This pilot study tests a topical cream of ruxolitinib to see if it helps heal PG ulcers in adults without adding systemic immunosuppressants.
-
Bright light therapy to help sleep after brain injury
This trial tests whether morning bright light therapy can improve sleep and related brain health markers in adults with a traumatic brain injury.
-
Transitioning from mavacamten to aficamten in obstructive HCM
This study tests whether switching from mavacamten to aficamten is feasible and safe for people with obstructive hypertrophic cardiomyopathy who are already on mavacamten.
-
Motor Activation Therapy after concussion: a targeted rehabilitation approach
This study tests a motor-activation focused physical therapy for people with persistent balance problems after a concussion to see if it improves their responses to imbalance.
-
L-fucose supplementation for adults with GLUT1 deficiency
This trial will test whether taking L-fucose supplements helps reduce ataxia and other symptoms in adults with GLUT1 deficiency.
-
Epetraborole for Mycobacterium abscessus lung disease
This study will test whether two oral doses of epetraborole can clear or improve lung infections in adults with mild to moderate Mycobacterium abscessus lung disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.