E Coli InfectionPhase 2NCT07318584
Cefotetan Therapy for Escherichia Coli Infections
A Phase 2 study testing Cefotetan, Carbapenems and Beta Lactam Antibiotics in people with E Coli Infection and ESBL Producing E.Coli, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- E Coli Infection, ESBL Producing E.Coli
- What is being tested?
- Cefotetan, Carbapenems and Beta Lactam Antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2026to Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Kristina L. Bajema, 503-494-1384, bajema@ohsu.edu
About this study
Official title: Cefotetan Therapy for Escherichia Coli 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 caused by E. coli. It will also measure cefotetan minimum inhibitory concentration (MIC) distributions and cefotetan trough serum concentrations.
Read the 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. 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.
- Conditions
- E Coli Infection, ESBL Producing E.Coli
- Being tested
- Cefotetan, Carbapenems, Beta Lactam Antibiotics
- Keywords
- cefotetan, cephamycin, ESBL producing E. coli, E. coli infection
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefotetanDrug
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
CarbapenemsDrug
Also called ertapenem, meropenem
Preferred antibiotic for ESBL E. coli infections: ertapenem. Minimum 1 dose within 24 hours of randomization.
Beta Lactam AntibioticsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cefotetan | Experimental | Not described Receives: Drug: Cefotetan |
| Standard of care antibiotics | Active comparator | Not described Receives: Drug: Carbapenems; Drug: Beta Lactam Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Absence of death, recurrent E. coli, bacteremia, or need for antibiotic treatment for recurrent E.coli genitourinary infection.
Measured: From randomization through 30 days.
Secondary outcomes (2)
Cefotetan MIC
Cefotetan MIC from E. coli isolated from blood and/or urine culture
Measured: Baseline
Cefotetan trough
Cefotetan serum trough obtained from a subset of participants randomized to cefotetan arm
Measured: Day 1 through 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start26 Jun 2026
- Primary completionOct 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for E Coli InfectionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Bajema, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318584
- Sponsor's protocol ID
- STUDY00028869
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tamma PD, Heil EL, Justo JA, Mathers AJ, Satlin MJ, Bonomo RA. Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections. Clin Infect Dis. 2024 Aug 7:ciae403. doi: 10.1093/cid/ciae403. Online ahead of print.
PubMed 39108079Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, Paterson DL; MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):984-994. doi: 10.1001/jama.2018.12163.
PubMed 30208454Stewart AG, Cottrell K, Henderson A, Vemuri K, Bauer MJ, Paterson DL, Harris PNA. In Vitro Activity of Cefotetan against ESBL-Producing Escherichia coli and Klebsiella pneumoniae Bloodstream Isolates from the MERINO Trial. Microbiol Spectr. 2021 Sep 3;9(1):e0022621. doi: 10.1128/Spectrum.00226-21. Epub 2021 Jul 7.
PubMed 34232101
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefotetan Therapy for Escherichia Coli Infections: a Prospective Phase II Pilot Study
- ClinicalTrials.gov ID
- NCT07318584
- Acronym / sponsor ID
- STUDY00028869
- Conditions
- E Coli Infection, ESBL Producing E.Coli
- Keywords
- cefotetan, cephamycin, ESBL producing E. coli, E. coli infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefotetan | Experimental | Drug: Cefotetan |
| Standard of care antibiotics | Active comparator | Drug: Carbapenems, Drug: Beta Lactam Antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefotetanMinimum 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 | Drug | Cefotetan |
| CarbapenemsAlso: ertapenem, meropenemPreferred antibiotic for ESBL E. coli infections: ertapenem. Minimum 1 dose within 24 hours of randomization. | Drug | Standard of care antibiotics |
| Beta Lactam AntibioticsBeta 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. | Drug | Standard of care antibiotics |
Primary outcome
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.
2 secondary outcomes
Cefotetan MIC
Time frame: Baseline
Cefotetan trough
Time frame: Day 1 through 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 39108079Tamma PD, Heil EL, Justo JA, Mathers AJ, Satlin MJ, Bonomo RA. Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections. Clin Infect Dis. 2024 Aug 7:ciae403. doi: 10.1093/cid/ciae403. Online ahead of print.
- Background: PubMed 30208454Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, Paterson DL; MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):984-994. doi: 10.1001/jama.2018.12163.
- Background: PubMed 34232101Stewart AG, Cottrell K, Henderson A, Vemuri K, Bauer MJ, Paterson DL, Harris PNA. In Vitro Activity of Cefotetan against ESBL-Producing Escherichia coli and Klebsiella pneumoniae Bloodstream Isolates from the MERINO Trial. Microbiol Spectr. 2021 Sep 3;9(1):e0022621. doi: 10.1128/Spectrum.00226-21. Epub 2021 Jul 7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for E Coli Infection
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
RecruitingPhase 1/2
Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant
E Coli Infections, Allogenic Transplant Patients
RecruitingPhase 2
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
Urinary Tract Infections
Not yet recruitingObservational study
Genomic and Phenotypic Diversity of Carbapenemase-producing Escherichia Coli Strains Circulating in Southern France
Antibiotic Resistance, Enterobacteriaceae Infections
RecruitingPhase 4
Lot-to-Lot Consistency Clinical Trial of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli)
Infection by Human Papilloma Virus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefotetan, Carbapenems and Beta Lactam Antibiotics in people with E Coli Infection and ESBL Producing E.Coli, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina L. Bajema (503-494-1384, bajema@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: From randomization through 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07318584, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.