Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units
Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s): Jan De Waele, MD, PhD, Principal Investigator, Affiliation: Ghent University Hospital
Overall contact: Jan De Waele, MD, PhD, Email: Jan.DeWaele@ugent.be
Summary
Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and
dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic
can't be changed, but the dosing scheme can be optimized. Recent studies proved that an
optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum
antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is
due to the pathophysiologic processes in the patients on intensive care units: increased
distribution volume, hypoproteinemia, organ failureā¦ The investigators guess that similar
processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and
cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in
seriously ill patients are better known, physicians are more confident prescribing these
drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously
ill patients, can help to give the physician the confidence to prescribe these
small-spectrum antibiotics.
In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic
acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a
central catheter on different moments after one administration of the antibiotic in the
steady state phase. All the patients are prescribed the antibiotics for the treatment of
their infections: they get the antibiotic therapy anyway. By measuring the concentrations on
different moments after one administration, the investigators can reconstruct the
pharmacokinetic function.
Clinical Details
Official title: Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid.Area under the serum concentration versus time curve (AUC) of Cefuroxime.
Secondary outcome: Severity of disease classification.Rate of organ failure. Concentration serum creatinin 24 hour urine creatinine clearance Change in fluid balance Concentration serum albumin
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients on the intensive care unit, who are treated with amoxicillin/clavulanic acid
or cefuroxime for an infection
Exclusion Criteria:
- informed consent lacking
- haematocrit < 21 %
- arterial catheter lacking
Locations and Contacts
Jan De Waele, MD, PhD, Email: Jan.DeWaele@ugent.be
Ghent University Hospital, Ghent 9000, Belgium; Recruiting Jan De Waele, MD, PhD, Email: Jan.DeWaele@ugent.be Jan De Waele, MD, PhD, Principal Investigator
Additional Information
Starting date: March 2012
Last updated: December 4, 2014
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