Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?
Pharmacokinetic Evaluation of Cefazolin, Ceftazidime, and Ciprofloxacin in Chronic Hemodialysis Patients
1 other identifier
observational
40
1 country
2
Brief Summary
This study aims to optimize the dosing of cefazolin, ceftazidime, and ciprofloxacin for patients on high-flux hemodialysis. For each antibiotic 20 participants will be enrolled and three blood samples will be collected from each participant. Antibiotic levels will be measured in each blood sample. This data will be used to develop population-pharmacokinetic models for each antibiotic. Finally, Monte Carlo simulations will be used to develop evidence-based dosing recommendations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2019
CompletedFirst Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedMay 16, 2024
May 1, 2024
4.5 years
March 2, 2020
May 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Volume of distribution (Vd) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis.
48 to 72 hours
Drug elimination (ke) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis.
Drug elimination (ke) during and between dialysis sessions
48 to 72 hours
Drug clearance (CL) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis.
48 to 72 hours
Study Arms (3)
Cefazolin
n = 20
Ceftazidime
n = 20
Ciprofloxacin
n = 20
Interventions
Eligibility Criteria
Adult patients on chronic intermittent high-flux hemodialysis being treated for infection.
You may qualify if:
- \>18 years old
- 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
You may not qualify if:
- Chronic liver disease, Child Pugh Class C or higher
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- The Kidney Foundation of Canadacollaborator
Study Sites (2)
Saint Boniface Hospital, Outpatient Hemodialysis Unit
Winnipeg, Manitoba, R2H 2A6, Canada
College of Pharmacy, University of Manitoba
Winnipeg, Manitoba, R3E 0T5, Canada
Biospecimen
Blood samples.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheryl A Zelenitsky, PharmD
University of Manitoba
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, College of Pharmacy, Rady Faculty of Health Sciences
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 24, 2020
Study Start
October 18, 2019
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
May 16, 2024
Record last verified: 2024-05