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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

Page last updated: August 23, 2015

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