Hemodialysis ComplicationNCT04319328
Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?
An observational study of Hemodialysis Complication and Infectious Disease, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Infectious Disease, End Stage Renal Disease
- What is being tested?
- Cefazolin and Ceftazidime
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Oct 2019to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients on chronic intermittent high-flux hemodialysis being treated for infection.
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Saint Boniface Hospital, Outpatient Hemodialysis Unit
Winnipeg, Manitoba, R2H 2A6
College of Pharmacy, University of Manitoba
Winnipeg, Manitoba, R3E 0T5
About this study
Official title: Pharmacokinetic Evaluation of Cefazolin, Ceftazidime, and Ciprofloxacin in Chronic Hemodialysis Patients
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.
Read the detailed description
The goal of this study is to optimize the dosing of three commonly used antibiotics, thereby improving the treatment of serious, often life-threatening infections in patients on intermittent high-flux hemodialysis (iHFHD).
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.
- Being tested
- Cefazolin, Ceftazidime
- Keywords
- Hemodialysis, Pharmacokinetics, Antibiotic Dosing, Cefazolin, Ceftazidime, Ciprofloxacin
- Medical subject headings
- Communicable Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Non-interventional pharmacokinetic evaluation
CeftazidimeDrug
Non-interventional pharmacokinetic evaluation
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | n = 20 Receives: Drug: Cefazolin | |
| Ceftazidime | n = 20 Receives: Drug: Ceftazidime | |
| Ciprofloxacin | n = 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of distribution (Vd) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis.
Measured: 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
Measured: 48 to 72 hours
Drug clearance (CL) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis.
Measured: 48 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start18 Oct 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- The Kidney Foundation of Canada
- Responsible party
- Principal investigator, Sheryl Zelenitsky, University of Manitoba
- Investigators
- Sheryl A Zelenitsky, PharmD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319328
- Sponsor's protocol ID
- H2019:031
- Status last verified
- May 2024
- First submitted
- 2 Mar 2020
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of Cefazolin, Ceftazidime, and Ciprofloxacin in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04319328
- Acronym / sponsor ID
- H2019:031
- Keywords
- Hemodialysis, Pharmacokinetics, Antibiotic Dosing, Cefazolin, Ceftazidime, Ciprofloxacin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- The Kidney Foundation of Canada
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study is to optimize the dosing of three commonly used antibiotics, thereby improving the treatment of serious, often life-threatening infections in patients on intermittent high-flux hemodialysis (iHFHD).
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | – | Drug: Cefazolinn = 20 |
| Ceftazidime | – | Drug: Ceftazidimen = 20 |
| Ciprofloxacin | – | –n = 20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients on chronic intermittent high-flux hemodialysis being treated for infection.
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinNon-interventional pharmacokinetic evaluation | Drug | Cefazolin |
| CeftazidimeNon-interventional pharmacokinetic evaluation | Drug | Ceftazidime |
Primary outcome
Volume of distribution (Vd) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis.
Time frame: 48 to 72 hours
Drug elimination (ke) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis.
Time frame: 48 to 72 hours
Drug elimination (ke) during and between dialysis sessions
Drug clearance (CL) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis.
Time frame: 48 to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl A Zelenitsky, PharmD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Complication and Infectious Disease, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of distribution (Vd) for cefazolin, ceftazidime, and ciprofloxacin in infected patients on chronic intermittent high-flux hemodialysis. (time frame: 48 to 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.