- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909698
Antibiotic Dosing in Patients on Intermittent Hemodialysis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Gent, Belgium, 9000
- Ghent University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hemodialysis patients on amoxicillin-clavulanic acid
The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for amoxicillin-clavulanic acid. |
During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.
|
Hemodialysis patients on ceftazidim
The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for ceftazidim. |
During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.
|
Hemodialysis patients on piperacillin-tazobactam
The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for piperacillin-tazobactam. |
During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.
|
Hemodialysis patients on vancomycin
The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for vancomycin. |
During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.
|
Hemodialysis patients on teicoplanin
The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for teicoplanin. |
During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
9/2016 - 12/2021
|
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. |
9/2016 - 12/2021
|
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%. |
9/2016 - 12/2021
|
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%. |
9/2016 - 12/2021
|
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%. |
9/2016 - 12/2021
|
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.
|
9/2016 - 12/2021
|
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.
|
9/2016 - 12/2021
|
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.
|
9/2016 - 12/2021
|
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.
|
9/2016 - 12/2021
|
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.
|
9/2016 - 12/2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
9/2016 - 12/2021
|
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
|
9/2016 - 12/2021
|
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
|
9/2016 - 12/2021
|
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
|
9/2016 - 12/2021
|
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
|
9/2016 - 12/2021
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Wim Van Biesen, PhD, MD, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGent_ABdosing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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