Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Department of hemodialysis, University Hospital of Tours
NOT_YET_RECRUITING
Orléans
Department of hemodialysis, University Hospital of Tours
RECRUITING
Tours
Contact Information
Primary
Valentin MAISONS, MD
valentin.maisons@univ-tours.fr
0247473746
Backup
Yoann Desvignes
y.desvignes@chu-tours.fr
Time Frame
Start Date: 2023-11-20
Estimated Completion Date: 2025-07
Participants
Target number of participants: 50
Treatments
Experimental: Cefazolin
20mg/kg to be administered in the hemodialysis circuit at the end of the 4-hour dialysis period, with no dosage adjustment planned afterwards.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Tours

This content was sourced from clinicaltrials.gov