Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?
NCT ID: NCT04319328
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2019-10-18
2024-04-30
Brief Summary
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Detailed Description
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The hypothesis is that current antibiotic dosing is suboptimal, thereby increasing the risk of poor outcomes including treatment failure, adverse drug reactions and antibiotic resistance.
A prospective, non-interventional pharmacokinetic (PK) study of cefazolin, ceftazidime, and ciprofloxacin will be conducted in the St. Boniface Hospital outpatient hemodialysis unit.
The 1st objective of this study is to measure the free and total plasma concentrations of cefazolin, ceftazidime, and ciprofloxacin in adult patients on iHFHD and receiving antibiotic therapy for suspected or proven infection. For each antibiotic 20 participants will be enrolled and three blood samples will be collected from each participant. Antibiotic concentrations will be measured using an ultra high performance liquid chromatograph mass spectrometer. Total antibiotic concentrations in plasma will be measured in all patient samples. To describe protein binding, free levels will also be measured in the first two samples collected from the first 10 patients for each antibiotic.
The 2nd objective of this study is to characterize the PK of cefazolin, ceftazidime, and ciprofloxacin in patients on iHFHD using population-PK modelling. Covariates with potential influence on PK such as gender, age, body weight, dialyzer type, blood and dialysate flow rates, duration of dialysis and Kt/Vurea will be investigated, and incorporated as appropriate. For each antibiotic, the best PK model will be selected using established goodness-of-fit tests, and then independently validated.
The 3rd objective of this study is to translate findings to patient care using Monte Carlo simulations to evaluate conventional antibiotic dosing and develop optimized evidence-based dosing recommendations for cefazolin, ceftazidime, and ciprofloxacin in patients on iHFHD.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Cefazolin
n = 20
Cefazolin
Non-interventional pharmacokinetic evaluation
Ceftazidime
n = 20
Ceftazidime
Non-interventional pharmacokinetic evaluation
Ciprofloxacin
n = 20
No interventions assigned to this group
Interventions
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Cefazolin
Non-interventional pharmacokinetic evaluation
Ceftazidime
Non-interventional pharmacokinetic evaluation
Eligibility Criteria
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Inclusion Criteria
* Proven or suspected infection
* Receiving cefazolin, ceftazidime, or ciprofloxacin for treatment
* Treatment course allows for collection of three 6 mL blood samples as per protocol
Exclusion Criteria
* Received study drug as part of a different treatment course in 1-week preceding start of new treatment course
* Acute kidney injury or recovering kidney function
18 Years
ALL
No
Sponsors
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The Kidney Foundation of Canada
OTHER
University of Manitoba
OTHER
Responsible Party
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Sheryl Zelenitsky
Professor, College of Pharmacy, Rady Faculty of Health Sciences
Principal Investigators
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Sheryl A Zelenitsky, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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Saint Boniface Hospital, Outpatient Hemodialysis Unit
Winnipeg, Manitoba, Canada
College of Pharmacy, University of Manitoba
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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H2019:031
Identifier Type: -
Identifier Source: org_study_id
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