Health TrialsbyHealthPanel

Cefotetan Therapy for Escherichia Coli Infections

ConditionsE Coli InfectionESBL Producing E.Coli
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cefotetan

    Drug

    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

    Drug

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

  • Beta Lactam Antibiotics

    Drug

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: CefotetanExperimental treatment 1 intervention
Group B: Standard of care antibioticsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Clinical success

Absence of death, recurrent E. coli, bacteremia, or need for antibiotic treatment for recurrent E.coli genitourinary infection.

Time frame
From randomization through 30 days.

Secondary outcomes

1

Cefotetan MIC

Cefotetan MIC from E. coli isolated from blood and/or urine culture

Time frame
Baseline
2

Cefotetan trough

Cefotetan serum trough obtained from a subset of participants randomized to cefotetan arm

Time frame
Day 1 through 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: