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Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

NCT06093269 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-12-05

No results posted yet for this study

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

  • Hemodialysis Catheter Infection
  • Infection, Bacterial

Interventions

BIOLOGICAL

Blood samples

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

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Valentin MAISONS, MD · University Hospital, Tours

  • Adrien LEMAIGNEN, MD-PhD · University Hospital, Tours

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093269 on ClinicalTrials.gov