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
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|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
Patients in the intensive care unit, with an infection which will be treated with Amoxicillin/Clavulanic Acid.
Patients in the intensive care unit, with an infection which will be treated with Cefuroxime.
- 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).
- 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).
- 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.
- 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).
- Concentration serum creatinin [ Time Frame: At day 1. ]
- 24 hour urine creatinine clearance [ Time Frame: At 24 hours ]Urine will be collected during 24 hours to measure the urine creatinine clearance.
- Change in fluid balance [ Time Frame: From 0 to 24 hours. ]Change in fluid balance will be measured.
- Concentration serum albumin [ Time Frame: At day 1. ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581047
|Contact: Jan De Waele, MD, PhD||Jan.DeWaele@ugent.be|
|Ghent University Hospital||Recruiting|
|Ghent, Belgium, 9000|
|Contact: Jan De Waele, MD, PhD Jan.DeWaele@ugent.be|
|Principal Investigator: Jan De Waele, MD, PhD|
|Principal Investigator:||Jan De Waele, MD, PhD||University Hospital, Ghent|