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

NCT01581047 | Completed

• 2 other identifiers: 2012/0782011-006107-35
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

amoxicillin; clavulanic acid; cefuroxime; Patients in the intensive care unit, with an infection which requires amoxicillin/clavulanic acid or cefuroxime

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Severity of disease classification.

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

• Rate of organ failure.

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

• Concentration serum creatinin

  At day 1.

• 24 hour urine creatinine clearance

  At 24 hours

• Change in fluid balance

  From 0 to 24 hours.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on the intensive care unit, with an infection (which requires amoxicillin/clavulanic acid or cefuroxime).

You may qualify if:

• patients on the intensive care unit, who are treated with amoxicillin/clavulanic acid or cefuroxime for an infection

You may not qualify if:

• informed consent lacking
• haematocrit \< 21 %
• arterial catheter lacking

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

8 serum samples will be taken per patient.

MeSH Terms

Conditions

Infections

Study Officials

• Jan De Waele, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: April 19, 2012
• Study Start: March 15, 2012
• Primary Completion: January 21, 2014
• Study Completion: May 7, 2014
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

BE (1)