Hemodialysis Catheter InfectionPhase 4CEFAZODIALNCT06093269
Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)
A Phase 4 study testing Blood samples in people with Hemodialysis Catheter Infection and Infection, Bacterial, run by University Hospital, Tours at 2 sites in France.
Trial summary
In chronic hemodialysis patients, bacteremia is most commonly caused by dialysis catheter infections. It is estimated that the vast majority (52-84%) of these infections are due to Gram-positive cocci, particularly Staphylococcus aureus (21-43%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Catheter Infection, Infection, Bacterial
- What is being tested?
- Blood samples
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Nov 2023to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subjects aged 18 or over
- On chronic intermittent dialysis
- With a stated indication for initiation of cefazolin either:
- For probabilistic treatment of a clinical presentation suggestive of MSSA infection
- for treatment of Gram-positive cocci bacteremia
- With the possibility of taking peripheral blood samples or samples from the dialysis machine until the next dialysis session at 48 hours.
Show all 9Show fewer
- Included within a maximum of one week after the first cefazolin injection.
- Affiliated with French social security
- Having signed an informed consent form
Who cannot join
- Pregnant or breast-feeding women
- Dialysis lasting less than 3 hours, which most often corresponds to "acute" dialysis or the start of chronic dialysis, which fundamentally changes the elimination profile.
- Allergy to cephalosporin and penicillin antibiotics (5-10% risk of cross-reactivity).
- Non-anuric subjects with inhibitors of tubular creatinine secretion:
- Curative-dose trimethoprim
- Cimetidine
- Ritonavir, Rilpivirine, Dolutegravir, Cobicistat
- Subjects under guardianship, curatorship or safeguard of justice
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of hemodialysis, University Hospital of Tours
Orléans, 45100
Department of hemodialysis, University Hospital of Tours
Tours, 37044
About this study
In chronic hemodialysis patients, bacteremia is most commonly caused by dialysis catheter infections. It is estimated that the vast majority (52-84%) of these infections are due to Gram-positive cocci, particularly Staphylococcus aureus (21-43%). Penicillin M (oxacillin and cloxacillin in France) is the reference beta-lactam for the treatment of invasive methicillin-sensitive S. aureus (MSSA) infections, but has not shown a prognostic benefit in large retrospective cohorts comparing penicillin M and cefazolin, at the expense of more frequent adverse events. Dosage in the chronic hemodialysis population is unclear because it is based on old studies.
Read the detailed description
In chronic hemodialysis patients, bacteremia is most commonly caused by dialysis catheter infections. It is estimated that the vast majority (52-84%) of these infections are due to Gram-positive cocci, particularly Staphylococcus aureus (21-43%). The uremia associated with kidney replacement therapy affects the immune system as a whole and is associated with an increased risk of infection. Bacterial infections are a major cause of mortality and morbidity in these patients. They are a major cause of hospitalization and the third leading cause of death after cardiovascular disease and treatment discontinuation.
Penicillin M (oxacillin and cloxacillin in France) is the reference beta-lactam for the treatment of invasive methicillin-sensitive S. aureus (MSSA) infections, but large retrospective cohorts comparing penicillin M and cefazolin have shown no prognostic benefit at the expense of more frequent adverse events. What's more, its short half-life means that it requires a more time-consuming hemodialysis protocol. Cefazolin is therefore the preferred treatment for invasive MSSA infections in the target population. This is because its clearance is slow in chronic renal failure patients during the replacement phase, and it can be administered as a single dose during hemodialysis sessions. The most recent French recommendations for cefazolin plasma concentration targets are to maintain the free form concentration at more than 4 times the minimum inhibitory concentration (MIC) for documented invasive MSSA infections or 40 - 80 mg/L (total form) for probabilistic treatment.
However, the pharmacokinetics of cefazolin at these high doses have been little studied in renal failure and dialysis patients, and dosing recommendations are mainly based on the doses recommended in the Summary of Product Characteristics (500mg at each hemodialysis session) up to 2-3g according to later pharmacokinetic and efficacy studies, or a fairly similar dosage but adapted to the weight of each patient (20mg/kg).
To our knowledge, there are no pharmacokinetic studies in infected chronic hemodialysis patients using modern assessment tools. Given the high interest in this drug in the target population, it seems essential to conduct such a study. In a second phase, a larger study could be conducted to validate the doses proposed in this study.
- Being tested
- Blood samples
- Keywords
- Cefazolin, Pharmacology, Nephrology, Hemodialysis, Infectiology
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
For all subjects (short kinetics):
- Pre-injection of cefazolin
- Start of next dialysis
- Two hours after start of subsequent dialysis
- End of next dialysis, before cefazolin administration
Only in hospitalized subjects (rich kinetics):
- 30 minutes, 1h and 2h after cefazolin injection, to describe the cefazolin peak and possible post-dialysis rebound
- 12h, 24h and 36h after cefazolin injection, to better describe cefazolin elimination and distribution
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Experimental | 20mg/kg to be administered in the hemodialysis circuit at the end of the 4-hour dialysis period, with no dosage adjustment planned afterwards. Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time during which cefazolin plasma concentration exceeds the target concentration of 40 mg/L.
Measured: 48 hours after injection
Secondary outcomes (18)
Occurrence of adverse events
Measured: Within 6 weeks of last dose
Early clinical efficacy - Persistence of fever >38°C
Early clinical efficacy (at 1 week from start of treatment) in cefazolin-susceptible patients, defined as absence of failure, composite endpoint including:
- Persistence of fever >38°C
- Persistence of positive blood cultures for the same germ(s)
- Death for infectious reasons
- Change of antibiotic therapy due to ineffectiveness
Measured: At 1 week from start of treatment
Early clinical efficacy - Persistence of positive blood cultures for the same germ(s)
Early clinical efficacy (at 1 week from start of treatment) in cefazolin-susceptible patients, defined as absence of failure, composite endpoint including:
- Persistence of fever >38°C
- Persistence of positive blood cultures for the same germ(s)
- Death for infectious reasons
- Change of antibiotic therapy due to ineffectiveness
Measured: At 1 week from start of treatment
Early clinical efficacy - Death for infectious reasons
Early clinical efficacy (at 1 week from start of treatment) in cefazolin-susceptible patients, defined as absence of failure, composite endpoint including:
- Persistence of fever >38°C
- Persistence of positive blood cultures for the same germ(s)
- Death for infectious reasons
- Change of antibiotic therapy due to ineffectiveness
Measured: At 1 week from start of treatment
Early clinical efficacy - Change of antibiotic therapy due to ineffectiveness
Early clinical efficacy (at 1 week from start of treatment) in cefazolin-susceptible patients, defined as absence of failure, composite endpoint including:
- Persistence of fever >38°C
- Persistence of positive blood cultures for the same germ(s)
- Death for infectious reasons
- Change of antibiotic therapy due to ineffectiveness
Measured: At 1 week from start of treatment
Late clinical efficacy - Persistence of positive blood cultures
Late clinical efficacy (at 6 weeks from the start of treatment) in patients with cefazolin-susceptible organisms, defined as absence of failure, composite endpoint including :
- Persistence of positive blood cultures
- Recurrence of initial infection
- Infectious death
- Change of antibiotic therapy due to ineffectiveness
Measured: At 6 weeks from the start of treatment
Late clinical efficacy - Recurrence of initial infection
Late clinical efficacy (at 6 weeks from the start of treatment) in patients with cefazolin-susceptible organisms, defined as absence of failure, composite endpoint including :
- Persistence of positive blood cultures
- Recurrence of initial infection
- Infectious death
- Change of antibiotic therapy due to ineffectiveness
Measured: At 6 weeks from the start of treatment
Late clinical efficacy - Infectious death
Late clinical efficacy (at 6 weeks from the start of treatment) in patients with cefazolin-susceptible organisms, defined as absence of failure, composite endpoint including :
- Persistence of positive blood cultures
- Recurrence of initial infection
- Infectious death
- Change of antibiotic therapy due to ineffectiveness
Measured: At 6 weeks from the start of treatment
Late clinical efficacy - Change of antibiotic therapy due to ineffectiveness
Late clinical efficacy (at 6 weeks from the start of treatment) in patients with cefazolin-susceptible organisms, defined as absence of failure, composite endpoint including :
- Persistence of positive blood cultures
- Recurrence of initial infection
- Infectious death
- Change of antibiotic therapy due to ineffectiveness
Measured: At 6 weeks from the start of treatment
Persistence of fever >38°C
All components of the composite endpoint "Early clinical efficacy" will be assessed separately.
Measured: At 1 week from start of treatment
Persistence of positive blood cultures for the same germ(s)
All components of the composite endpoint "Early clinical efficacy" will be assessed separately.
Measured: At 1 week from start of treatment
Death for infectious reasons
All components of the composite endpoint "Early clinical efficacy" will be assessed separately.
Measured: At 1 week from start of treatment
Change of antibiotic therapy due to ineffectiveness
All components of the composite endpoint "Early clinical efficacy" will be assessed separately.
Measured: At 1 week from start of treatment
Persistence of positive blood cultures
All components of the composite endpoint "Late clinical efficacy" will be assessed separately.
Measured: At 6 weeks from the start of treatment
Recurrence of initial infection
All components of the composite endpoint "Late clinical efficacy" will be assessed separately.
Measured: At 6 weeks from the start of treatment
Infectious death
All components of the composite endpoint "Late clinical efficacy" will be assessed separately.
Measured: At 6 weeks from the start of treatment
Change of antibiotic therapy due to ineffectiveness
All components of the composite endpoint "Late clinical efficacy" will be assessed separately.
Measured: At 6 weeks from the start of treatment
Characterizing the pharmacokinetic variability of Cefazolin
Characterizing the pharmacokinetic variability of Cefazolin with the occurrence of under- or over-exposure (concentration below 40 mg/L or above 80mg/L)
Measured: 48 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Catheter InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentin MAISONS, MD, Study director, University Hospital, ToursAdrien LEMAIGNEN, MD-PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093269
- Sponsor's protocol ID
- DR220268
- Other IDs
- EuCT number
- Acronym
- CEFAZODIAL
- Status last verified
- Nov 2025
- First submitted
- 9 Oct 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)
- ClinicalTrials.gov ID
- NCT06093269
- Acronym / sponsor ID
- CEFAZODIAL / DR220268
- Keywords
- Cefazolin, Pharmacology, Nephrology, Hemodialysis, Infectiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (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.
In chronic hemodialysis patients, bacteremia is most commonly caused by dialysis catheter infections. It is estimated that the vast majority (52-84%) of these infections are due to Gram-positive cocci, particularly Staphylococcus aureus (21-43%). Penicillin M (oxacillin and cloxacillin in France) is the reference beta-lactam for the treatment of invasive methicillin-sensitive S. aureus (MSSA) infections, but has not shown a prognostic benefit in large retrospective cohorts comparing penicillin M and cefazolin, at the expense of more frequent adverse events. Dosage in the chronic hemodialysis population is unclear because it is based on old studies.
Detailed description
In chronic hemodialysis patients, bacteremia is most commonly caused by dialysis catheter infections. It is estimated that the vast majority (52-84%) of these infections are due to Gram-positive cocci, particularly Staphylococcus aureus (21-43%). The uremia associated with kidney replacement therapy affects the immune system as a whole and is associated with an increased risk of infection. Bacterial infections are a major cause of mortality and morbidity in these patients. They are a major cause of hospitalization and the third leading cause of death after cardiovascular disease and treatment discontinuation.
Penicillin M (oxacillin and cloxacillin in France) is the reference beta-lactam for the treatment of invasive methicillin-sensitive S. aureus (MSSA) infections, but large retrospective cohorts comparing penicillin M and cefazolin have shown no prognostic benefit at the expense of more frequent adverse events. What's more, its short half-life means that it requires a more time-consuming hemodialysis protocol. Cefazolin is therefore the preferred treatment for invasive MSSA infections in the target population. This is because its clearance is slow in chronic renal failure patients during the replacement phase, and it can be administered as a single dose during hemodialysis sessions. The most recent French recommendations for cefazolin plasma concentration targets are to maintain the free form concentration at more than 4 times the minimum inhibitory concentration (MIC) for documented invasive MSSA infections or 40 - 80 mg/L (total form) for probabilistic treatment.
However, the pharmacokinetics of cefazolin at these high doses have been little studied in renal failure and dialysis patients, and dosing recommendations are mainly based on the doses recommended in the Summary of Product Characteristics (500mg at each hemodialysis session) up to 2-3g according to later pharmacokinetic and efficacy studies, or a fairly similar dosage but adapted to the weight of each patient (20mg/kg).
To our knowledge, there are no pharmacokinetic studies in infected chronic hemodialysis patients using modern assessment tools. Given the high interest in this drug in the target population, it seems essential to conduct such a study. In a second phase, a larger study could be conducted to validate the doses proposed in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Experimental | Biological: Blood samples20mg/kg to be administered in the hemodialysis circuit at the end of the 4-hour dialysis period, with no dosage adjustment planned afterwards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects aged 18 or over
- On chronic intermittent dialysis
- With a stated indication for initiation of cefazolin either:
- With the possibility of taking peripheral blood samples or samples from the dialysis machine until the next dialysis session at 48 hours.
- Included within a maximum of one week after the first cefazolin injection.
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding women
- Dialysis lasting less than 3 hours, which most often corresponds to "acute" dialysis or the start of chronic dialysis, which fundamentally changes the elimination profile.
- Allergy to cephalosporin and penicillin antibiotics (5-10% risk of cross-reactivity).
- Non-anuric subjects with inhibitors of tubular creatinine secretion:
- Subjects under guardianship, curatorship or safeguard of justice
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 |
|---|---|---|
| Blood samplesFor all subjects (short kinetics): * Pre-injection of cefazolin * Start of next dialysis * Two hours after start of subsequent dialysis * End of next dialysis, before cefazolin administration Only in hospitalized subjects (rich kinetics): * 30 minutes, 1h and 2h after cefazolin injection, to describe the cefazolin peak and possible post-dialysis rebound * 12h, 24h and 36h after cefazolin injection, to better describe cefazolin elimination and distribution | Biological | Cefazolin |
Primary outcome
Time during which cefazolin plasma concentration exceeds the target concentration of 40 mg/L.
Time frame: 48 hours after injection
18 secondary outcomes
Occurrence of adverse events
Time frame: Within 6 weeks of last dose
Early clinical efficacy - Persistence of fever >38°C
Time frame: At 1 week from start of treatment
Early clinical efficacy - Persistence of positive blood cultures for the same germ(s)
Time frame: At 1 week from start of treatment
Early clinical efficacy - Death for infectious reasons
Time frame: At 1 week from start of treatment
Early clinical efficacy - Change of antibiotic therapy due to ineffectiveness
Time frame: At 1 week from start of treatment
Late clinical efficacy - Persistence of positive blood cultures
Time frame: At 6 weeks from the start of treatment
Late clinical efficacy - Recurrence of initial infection
Time frame: At 6 weeks from the start of treatment
Late clinical efficacy - Infectious death
Time frame: At 6 weeks from the start of treatment
Late clinical efficacy - Change of antibiotic therapy due to ineffectiveness
Time frame: At 6 weeks from the start of treatment
Persistence of fever >38°C
Time frame: At 1 week from start of treatment
Persistence of positive blood cultures for the same germ(s)
Time frame: At 1 week from start of treatment
Death for infectious reasons
Time frame: At 1 week from start of treatment
Change of antibiotic therapy due to ineffectiveness
Time frame: At 1 week from start of treatment
Persistence of positive blood cultures
Time frame: At 6 weeks from the start of treatment
Recurrence of initial infection
Time frame: At 6 weeks from the start of treatment
Infectious death
Time frame: At 6 weeks from the start of treatment
Change of antibiotic therapy due to ineffectiveness
Time frame: At 6 weeks from the start of treatment
Characterizing the pharmacokinetic variability of Cefazolin
Time frame: 48 hours after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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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.
Valentin MAISONS, MD study director
University Hospital, Tours
Adrien LEMAIGNEN, MD-PhD study director
University Hospital, Tours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood samples in people with Hemodialysis Catheter Infection and Infection, Bacterial, run by University Hospital, Tours at 2 sites in France.
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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Time during which cefazolin plasma concentration exceeds the target concentration of 40 mg/L. (time frame: 48 hours after injection). 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 5 Dec 2025.