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Cefotetan Therapy for Escherichia Coli Infections

NCT07318584 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-01-06

No results posted yet for this study

Summary

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.

Conditions

  • E Coli Infection
  • ESBL Producing E.Coli

Interventions

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

DRUG

Carbapenems

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

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-02-29
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318584 on ClinicalTrials.gov