Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Time during which cefazolin plasma concentration exceeds the target concentration of 40 mg/L. — 48 hours after injection

Trial sites (2)

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