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OpenTrials
Completed

NCT Number: NCT03909698

Antibiotic Dosing in Patients on Intermittent Hemodialysis

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.

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Key information

Conditions

Kidney Failure, Chronic Antibiotics Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and urine sampling

Other

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

Primary outcomes

  1. Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin

    Time frame: 9/2016 - 12/2021

    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.

  2. Blood concentrations with maximal antimicrobial activity versus current dosing regimens for teicoplanin

    Time frame: 9/2016 - 12/2021

    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.

  3. Blood concentrations with maximal antimicrobial activity versus current dosing regimens for amoxicillin-clavulanic acid

    Time frame: 9/2016 - 12/2021

    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%.

  4. Blood concentrations with maximal antimicrobial activity versus current dosing regimens for piperacillin-tazobactam

    Time frame: 9/2016 - 12/2021

    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%.

  5. Blood concentrations with maximal antimicrobial activity versus current dosing regimens for ceftazidim

    Time frame: 9/2016 - 12/2021

    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%.

  6. Pharmacokinetics of vancomycin in patients undergoing intermittent hemodialysis

    Time frame: 9/2016 - 12/2021

    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.

  7. Pharmacokinetics of teicoplanin in patients undergoing intermittent hemodialysis

    Time frame: 9/2016 - 12/2021

    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.

  8. Pharmacokinetics of amoxicillin-clavulanic acid in patients undergoing intermittent hemodialysis

    Time frame: 9/2016 - 12/2021

    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. Pharmacokinetics of piperacillin-tazobactam in patients undergoing intermittent hemodialysis

    Time frame: 9/2016 - 12/2021

    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.

  10. Pharmacokinetics of ceftazidim in patients undergoing intermittent hemodialysis

    Time frame: 9/2016 - 12/2021

    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.

Secondary outcomes

  1. Dialyser extraction rate of vancomycin

    Time frame: 9/2016 - 12/2021

    From dialyser inlet and outlet samples, the extraction ratio is calculated for vancomycin and entered in the kinetic analysis

  2. Dialyser extraction rate of teicoplanin

    Time frame: 9/2016 - 12/2021

    From dialyser inlet and outlet samples, the extraction ratio is calculated for teicoplanin and entered in the kinetic analysis

  3. Dialyser extraction rate of amoxicillin-clavulanic acid

    Time frame: 9/2016 - 12/2021

    From dialyser inlet and outlet samples, the extraction ratio is calculated for amoxicillin-clavulanic acid and entered in the kinetic analysis

  4. Dialyser extraction rate of piperacillin-tazobactam

    Time frame: 9/2016 - 12/2021

    From dialyser inlet and outlet samples, the extraction ratio is calculated for piperacillin-tazobactam and entered in the kinetic analysis

  5. Dialyser extraction rate of ceftazidim

    Time frame: 9/2016 - 12/2021

    From dialyser inlet and outlet samples, the extraction ratio is calculated for ceftazidim and entered in the kinetic analysis

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2019
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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