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

Infection Clinical Trial

— AMOCEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581047
• Other study ID #: 2012/078
• Secondary ID: 2011-006107-35
• Status: Completed
• Start date: March 15, 2012
• Est. completion date: May 7, 2014

Study information

• Verified date: September 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 7, 2014
• Est. primary completion date: January 21, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Infections

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid.	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).	Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration
Primary	Area under the serum concentration versus time curve (AUC) of Cefuroxime.	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).	Before and at 15, 30, 45, 60, 120, 240 and 480 minutes after administration
Secondary	Severity of disease classification.	This will be assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE2)-score.	At date of admission (day 1) and dismissal (up to 3 months).
Secondary	Rate of organ failure.	This will be assessed using the Sequential Organ Failure Assessment score (SOFA-score).	At date of admission (day 1) and dismissal (up to 3 months).
Secondary	Concentration serum creatinin		At day 1.
Secondary	24 hour urine creatinine clearance	Urine will be collected during 24 hours to measure the urine creatinine clearance.	At 24 hours
Secondary	Change in fluid balance	Change in fluid balance will be measured.	From 0 to 24 hours.
Secondary	Concentration serum albumin		At day 1.