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Status:

ACTIVE_NOT_RECRUITING

Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

Lead Sponsor:

University Hospital, Tours

Conditions:

Hemodialysis Catheter Infection

Infection, Bacterial

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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.
  • Allergy to cephalosporin and penicillin antibiotics (5-10% risk of cross-reactivity).
  • Non-anuric subjects with inhibitors of tubular creatinine secretion:
  • Curative-dose trimethoprim
  • Cimetidine
  • Ritonavir, Rilpivirine, Dolutegravir, Cobicistat
  • Subjects under guardianship, curatorship or safeguard of justice

Key Trial Info

Start Date :

November 20 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2025

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT06093269

Start Date

November 20 2023

End Date

December 1 2025

Last Update

December 5 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Department of hemodialysis, University Hospital of Tours

Orléans, France, 45100

2

Department of hemodialysis, University Hospital of Tours

Tours, France, 37044