Cefotetan Therapy for Escherichia Coli Infections

Conditions

• E Coli Infection
• ESBL Producing E.Coli

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Mar 31, 2026

Status verified

Jan 2026

Primary completion

Feb 29, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cefotetan
• Active Comparator: Standard of care antibiotics

Primary Outcome Measure

Clinical success [ Time Frame: From randomization through 30 days. ]

Central Contacts

• Kristina L. Bajema
  503-494-1384
  [email protected]
• James Lewis
  503-494-1384
  [email protected]

Locations (1)

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