Cefazolin pharmacokinetics in hemodialysis patients

Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

This study tests how cefazolin works in patients on hemodialysis to find the best way to dose it for treating infections caused by certain bacteria.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Tours (other)
• Locations: 2 sites (Orléans and 1 other locations)
• Trial ID: NCT06093269 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics of cefazolin in patients undergoing chronic hemodialysis, focusing on its effectiveness against infections caused by methicillin-sensitive Staphylococcus aureus (MSSA). It aims to determine optimal dosing strategies for cefazolin, which is preferred over traditional treatments due to its longer half-life and ability to be administered as a single dose during dialysis sessions. Blood samples will be collected to analyze cefazolin levels and ensure they meet therapeutic targets. The study seeks to clarify dosing recommendations based on the unique pharmacological needs of this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over who are on chronic intermittent dialysis and require cefazolin for suspected MSSA infections.

Not a fit: Patients who are pregnant, breastfeeding, or have allergies to cephalosporins and penicillin antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for hemodialysis patients suffering from serious bacterial infections, potentially reducing morbidity and mortality.

How similar studies have performed: Previous studies have indicated that cefazolin may be more effective than traditional treatments for MSSA infections in hemodialysis patients, suggesting a promising avenue for this research.

Eligibility criteria

Inclusion Criteria:

1. Subjects aged 18 or over
2. On chronic intermittent dialysis
3. With a stated indication for initiation of cefazolin either:

   1. For probabilistic treatment of a clinical presentation suggestive of MSSA infection
   2. for treatment of Gram-positive cocci bacteremia
4. With the possibility of taking peripheral blood samples or samples from the dialysis machine until the next dialysis session at 48 hours.
5. Included within a maximum of one week after the first cefazolin injection.
6. Affiliated with French social security
7. Having signed an informed consent form

Exclusion Criteria:

1. Pregnant or breast-feeding women
2. 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.
3. Allergy to cephalosporin and penicillin antibiotics (5-10% risk of cross-reactivity).
4. Non-anuric subjects with inhibitors of tubular creatinine secretion:

   1. Curative-dose trimethoprim
   2. Cimetidine
   3. Ritonavir, Rilpivirine, Dolutegravir, Cobicistat
5. Subjects under guardianship, curatorship or safeguard of justice

Where this trial is running

Orléans and 1 other locations

• Department of hemodialysis, University Hospital of Tours — Orléans, France (NOT_YET_RECRUITING)
• Department of hemodialysis, University Hospital of Tours — Tours, France (RECRUITING)

Study contacts

• Study coordinator: Valentin MAISONS, MD

Conditions: Hemodialysis Catheter Infection, Infection, Bacterial, Cefazolin, Pharmacology, Nephrology, Hemodialysis, Infectiology