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NCT Number: NCT01581047

Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units

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 failure… 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid.

    Time frame: Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration

    The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).

  2. Area under the serum concentration versus time curve (AUC) of Cefuroxime.

    Time frame: Before and at 15, 30, 45, 60, 120, 240 and 480 minutes after administration

    The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).

Secondary outcomes

  1. Severity of disease classification.

    Time frame: At date of admission (day 1) and dismissal (up to 3 months).

    This will be assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE2)-score.

  2. Rate of organ failure.

    Time frame: At date of admission (day 1) and dismissal (up to 3 months).

    This will be assessed using the Sequential Organ Failure Assessment score (SOFA-score).

  3. Concentration serum creatinin

    Time frame: At day 1.

  4. 24 hour urine creatinine clearance

    Time frame: At 24 hours

    Urine will be collected during 24 hours to measure the urine creatinine clearance.

  5. Change in fluid balance

    Time frame: From 0 to 24 hours.

    Change in fluid balance will be measured.

  6. Concentration serum albumin

    Time frame: At day 1.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: AMOCEF

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2012
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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