Pharmacokinetics study of Cefazolin in haemodialysis

Phase 1

Recruiting

• Conditions: Chronic haemodialysis patients suffering from infection.; MedDRA version: 21.0Level: LLTClassification code: 10007810Term: Catheter related infection Class: 10021881; MedDRA version: 21.1Level: LLTClassification code: 10066622Term: Chronic hemodialysis Class: 10042613; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-506734-73-00
• Lead Sponsor: Centre Hospitalier Regional Universitaire De Tours

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-13
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Subjects aged 18 years or over, On chronic intermittent dialysis, With a stated indication for initiation of cefazolin either : 1/ For probabilistic treatment of a clinical presentation suggestive of SAMS infection 2/ For treatment of Gram-positive cocci bacteremia, With the possibility of taking peripheral blood samples or blood samples from the dialysis machine until the next dialysis session at 48 hours, Covered by or entitled to social security, Signed informed consent form

Exclusion Criteria

Pregnant or breastfeeding woman, 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, Patient following any measures of legal presentation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Description of the pharmacokinetics of cefazolin in chronic haemodialysis patients with infections, as part of routine care.;Secondary Objective: Evaluation of the safety profile of cefazolin (within 6 weeks of the last dose), Evaluation of the link between dosage and clinical efficacy (early and late), Identification of factors predictive of under/over exposure to cefazolin, Suggest dosage regimens to optimise exposure to cefazolin.;Primary end point(s): Time during which the plasma concentration of cefazolin is greater than the target concentration of 40 mg/L.