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Old antibiotic gets a second look for tough e. coli infections

NCT ID NCT07318584

Disease control Sponsor: Oregon Health and Science University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study will test whether the antibiotic cefotetan works as well as standard treatments for E. coli infections in the blood or urinary tract. About 84 hospitalized adults will be randomly assigned to receive cefotetan or usual care. The goal is to see if cefotetan can successfully treat the infection without the need for additional antibiotics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cefotetan (an antibiotic)
What this could lead to
If successful, cefotetan could become a new treatment option for certain E. coli infections, potentially reducing the need for stronger antibiotics.
What could go wrong
This is a small, early-phase pilot study. It may not show a clear benefit over existing antibiotics, and results may not apply to all E. coli infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

escherichia coli infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

E. coli infection Esbl producing E.coli

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

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