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

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ClinicalTrials.gov Identifier: NCT01581047
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : April 19, 2012
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 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.


Condition or disease
Infection

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units
Study Start Date : March 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Amoxicillin/Clavulanic Acid
Patients in the intensive care unit, with an infection which will be treated with Amoxicillin/Clavulanic Acid.
Cefuroxime
Patients in the intensive care unit, with an infection which will be treated with Cefuroxime.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Biospecimen Retention:   Samples Without DNA
8 serum samples will be taken per patient.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients on the intensive care unit, with an infection (which requires amoxicillin/clavulanic acid or cefuroxime).
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581047


Contacts
Contact: Jan De Waele, MD, PhD Jan.DeWaele@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Jan De Waele, MD, PhD       Jan.DeWaele@ugent.be   
Principal Investigator: Jan De Waele, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Jan De Waele, MD, PhD University Hospital, Ghent
More Information

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01581047     History of Changes
Other Study ID Numbers: 2012/078
2011-006107-35 ( EudraCT Number )
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
amoxicillin
clavulanic acid
cefuroxime
Patients in the intensive care unit, with an infection which requires amoxicillin/clavulanic acid or cefuroxime

Additional relevant MeSH terms:
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Cefuroxime
Cefuroxime axetil
Lactams
beta-Lactams
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors