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Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

Study acronym: CEFAZODIAL
StatusActive, Not Recruiting
PhasePhase 4
Started2023-11-20
View on ClinicalTrials.gov ↗

Amendment history

2025-11-27
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-07→2025-12
Completion date2025-07→2025-12
Enrollment targetestimated 50→confirmed 32
Study sitesdetails revised at 2 of 2 sites
2023-11-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-11-20
Study sitesdetails revised at 2 of 2 sites
2023-10-16
Original filing
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.
Trial Details
NCT Number NCT06093269
Lead Sponsor University Hospital, Tours
Conditions Hemodialysis Catheter Infection, Infection, Bacterial
Enrollment 32 participants
Start Date 2023-11-20
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-05