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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03909698
Other study ID # UGent_ABdosing
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2016
Est. completion date March 31, 2022

Study information

Verified date August 2021
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating pharmacokinetics-pharmacodynamics (PK-PD) target attainment. A population pharmacokinetic study is performed to assist the selection of the optimal individualized dose for patients undergoing intermittent dialysis, taking into consideration as many relevant variables as possible.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients with end-stage kidney disease, requiring intermittent hemodialysis - patient receiving antibiotic treatment for documented or presumed infection (vancomycin, teicoplanin, amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) Exclusion Criteria: - pregnant woman - absence of written informed consent from the patient - known hypersensitivity or contra-indication to glycopeptides or beta-lactam antibiotics

Study Design


Intervention

Other:
Blood and urine sampling
During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.

Locations

Country Name City State
Belgium Ghent University Hospital Gent

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Ghent University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin Measured free and total concentration of the glycopeptide vancomycin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be >=400 for vancomycin.
9/2016 - 12/2021
Primary Blood concentrations with maximal antimicrobial activity versus current dosing regimens for teicoplanin Measured free and total concentration of the glycopeptide teicoplanin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be >=750 for teicoplanin.
9/2016 - 12/2021
Primary Blood concentrations with maximal antimicrobial activity versus current dosing regimens for amoxicillin-clavulanic acid Measured concentration of the beta-lactam amoxicillin-clavulanic acid is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
9/2016 - 12/2021
Primary Blood concentrations with maximal antimicrobial activity versus current dosing regimens for piperacillin-tazobactam Measured concentration of the beta-lactam piperacillin-tazobactam is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
9/2016 - 12/2021
Primary Blood concentrations with maximal antimicrobial activity versus current dosing regimens for ceftazidim Measured concentration of the beta-lactam ceftazidim is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
9/2016 - 12/2021
Primary Pharmacokinetics of vancomycin in patients undergoing intermittent hemodialysis Population pharmacokinetic modeling is performed based on the measured vancomycin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured vancomycin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance. 9/2016 - 12/2021
Primary Pharmacokinetics of teicoplanin in patients undergoing intermittent hemodialysis Population pharmacokinetic modeling is performed based on the measured teicoplanin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured teicoplanin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance. 9/2016 - 12/2021
Primary Pharmacokinetics of amoxicillin-clavulanic acid in patients undergoing intermittent hemodialysis Population pharmacokinetic modeling is performed based on the measured amoxicillin-clavulanic acid concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured amoxicillin-clavulanic acid concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance. 9/2016 - 12/2021
Primary Pharmacokinetics of piperacillin-tazobactam in patients undergoing intermittent hemodialysis Population pharmacokinetic modeling is performed based on the measured piperacillin-tazobactam concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured piperacillin-tazobactam concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance. 9/2016 - 12/2021
Primary Pharmacokinetics of ceftazidim in patients undergoing intermittent hemodialysis Population pharmacokinetic modeling is performed based on the measured ceftazidim concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured ceftazidim concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance. 9/2016 - 12/2021
Secondary Dialyser extraction rate of vancomycin From dialyser inlet and outlet samples, the extraction ratio is calculated for vancomycin and entered in the kinetic analysis 9/2016 - 12/2021
Secondary Dialyser extraction rate of teicoplanin From dialyser inlet and outlet samples, the extraction ratio is calculated for teicoplanin and entered in the kinetic analysis 9/2016 - 12/2021
Secondary Dialyser extraction rate of amoxicillin-clavulanic acid From dialyser inlet and outlet samples, the extraction ratio is calculated for amoxicillin-clavulanic acid and entered in the kinetic analysis 9/2016 - 12/2021
Secondary Dialyser extraction rate of piperacillin-tazobactam From dialyser inlet and outlet samples, the extraction ratio is calculated for piperacillin-tazobactam and entered in the kinetic analysis 9/2016 - 12/2021
Secondary Dialyser extraction rate of ceftazidim From dialyser inlet and outlet samples, the extraction ratio is calculated for ceftazidim and entered in the kinetic analysis 9/2016 - 12/2021
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