Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL) (NCT06093269) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)
France32 participantsStarted 2023-11-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Time during which cefazolin plasma concentration exceeds the target concentration of 40 mg/L.