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Clinical Trials/ACTRN12609000069257
ACTRN12609000069257RecruitingPhase 4

In intensive care patients with sepsis, are extended (prolonged) infusions of cefepime, compared to conventional intermittent dosing, more effective in achieving and maintaining plasma concentrations above pharmacodynamic breakpoints?

The Alfred0 sites30 target enrollmentStarted: January 28, 2009Last updated:

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
30

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
All

Inclusion Criteria

  • An adult intensive care patient who: Has been prescribed cefepime according to The Alfred Intensive Care Unit (ICU) Antibiotic Guidelines (ie. after 7 days of hospital admission and requiring empiric or directed anti-microbial treatment); Is likely to remain in ICU for at least three days from enrolment; Has an arterial line already in situ for blood sampling.

Exclusion Criteria

  • 1. Any documented allergy or adverse reaction to cefepime or other cephalosporin antibiotic or significant / serious adverse reaction to other beta-lactam or monobactam antibiotics which would normally preclude the prescribing of cefepime according to the Alfred ICU Antibiotic Guidelines.
  • 2. Moderate to severe renal impairment (calculated estimated glomular filtration ratre (eGRF) <30mL/min at enrolment) or need for continous renal replacement therapy or intermittent heamodialysis.
  • 3. Patients with significant burns (ie. greater than 15% body surface area)
  • 4. Patients with extracorporeal circuits (eg. extracorporeal membranous oxygenation, ventricular assist devices)
  • 5. All transplant patients including solid organ and bone marrow transplants
  • 6. Pregnancy
  • 7. Inclusion in other study protocols which preclude enrolment in this study.

Investigators

Sponsor
The Alfred

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