Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

NCT06093269 | Active Not Recruiting Phase 4

• 2 other identifiers: DR220268EuCT number
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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%). 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.

Conditions

Infection, Bacterial; Hemodialysis Catheter Infection

Keywords

Cefazolin; Pharmacology; Nephrology; Hemodialysis; Infectiology

Outcome Measures

Primary Outcomes (1)

• Time during which cefazolin plasma concentration exceeds the target concentration of 40 mg/L.

  48 hours after injection

Secondary Outcomes (18)

• Occurrence of adverse events

  Within 6 weeks of last dose

• Early clinical efficacy - Persistence of fever >38°C

  At 1 week from start of treatment

• Early clinical efficacy - Persistence of positive blood cultures for the same germ(s)

  At 1 week from start of treatment

• Early clinical efficacy - Death for infectious reasons

  At 1 week from start of treatment

• Early clinical efficacy - Change of antibiotic therapy due to ineffectiveness

  At 1 week from start of treatment

Study Arms (1)

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.

Biological: Blood samples

Interventions

Blood samples BIOLOGICAL

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

Cefazolin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Included within a maximum of one week after the first cefazolin injection.
• Affiliated with French social security
• Having signed an informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (2)

Department of hemodialysis, University Hospital of Tours

Orléans, 45100, France

Location

Department of hemodialysis, University Hospital of Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Valentin MAISONS, MD

  University Hospital, Tours

  STUDY DIRECTOR

• Adrien LEMAIGNEN, MD-PhD

  University Hospital, Tours

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 23, 2023
• Study Start: November 20, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

FR (2)