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ACTIVE NOT RECRUITING
NCT06093269
PHASE4

Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2023-11-20

Completion Date

2025-12

Last Updated

2025-12-05

Healthy Volunteers

No

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

Locations (2)

Department of hemodialysis, University Hospital of Tours

Orléans, France

Department of hemodialysis, University Hospital of Tours

Tours, France