Clinical trial NCT03909698: Antibiotic Dosing in Patients on Intermittent Hemodialysis
Official title: Antibiotic Dosing in Patients on Intermittent Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Chronic
Antibiotics
Hemodialysis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2019-04-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Per antibiotic agent, up to 30 patients are included. The final needed number is anticipated by the numer of smamples per patient and the pharmacokinetic modeling.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin
timeFrame: 9/2016 - 12/2021
measure: Blood concentrations with maximal antimicrobial activity versus current dosing regimens for teicoplanin
timeFrame: 9/2016 - 12/2021
measure: Blood concentrations with maximal antimicrobial activity versus current dosing regimens for amoxicillin-clavulanic acid
timeFrame: 9/2016 - 12/2021
measure: Blood concentrations with maximal antimicrobial activity versus current dosing regimens for piperacillin-tazobactam
timeFrame: 9/2016 - 12/2021
measure: Blood concentrations with maximal antimicrobial activity versus current dosing regimens for ceftazidim
timeFrame: 9/2016 - 12/2021
measure: Pharmacokinetics of vancomycin in patients undergoing intermittent hemodialysis
timeFrame: 9/2016 - 12/2021
measure: Pharmacokinetics of teicoplanin in patients undergoing intermittent hemodialysis
timeFrame: 9/2016 - 12/2021
measure: Pharmacokinetics of amoxicillin-clavulanic acid in patients undergoing intermittent hemodialysis
timeFrame: 9/2016 - 12/2021
measure: Pharmacokinetics of piperacillin-tazobactam in patients undergoing intermittent hemodialysis
timeFrame: 9/2016 - 12/2021
measure: Pharmacokinetics of ceftazidim in patients undergoing intermittent hemodialysis
timeFrame: 9/2016 - 12/2021
Secondary outcomes:
measure: Dialyser extraction rate of vancomycin
timeFrame: 9/2016 - 12/2021
measure: Dialyser extraction rate of teicoplanin
timeFrame: 9/2016 - 12/2021
measure: Dialyser extraction rate of amoxicillin-clavulanic acid
timeFrame: 9/2016 - 12/2021
measure: Dialyser extraction rate of piperacillin-tazobactam
timeFrame: 9/2016 - 12/2021
measure: Dialyser extraction rate of ceftazidim
timeFrame: 9/2016 - 12/2021
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Wim Van Biesen, PhD, MD
role: STUDY_CHAIR
References: