Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093269
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-10-09
Brief Title:
Pharmacokinetics Study of Cefazolin in Hemodialysis CEFAZODIAL
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Pharmacokinetics Study of Cefazolin in Hemodialysis CEFAZODIAL
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEFAZODIAL
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 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
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 particularly Staphylococcus aureus 21-43 The uremia associated with kidney replacement therapy affects the immune system as a whole and is associated with an increased risk of infection Bacterial infections are a major cause of mortality and morbidity in these patients They are a major cause of hospitalization and the third leading cause of death after cardiovascular disease and treatment discontinuation
Penicillin M oxacillin and cloxacillin in France is the reference beta-lactam for the treatment of invasive methicillin-sensitive S aureus MSSA infections but large retrospective cohorts comparing penicillin M and cefazolin have shown no prognostic benefit at the expense of more frequent adverse events Whats more its short half-life means that it requires a more time-consuming hemodialysis protocol Cefazolin is therefore the preferred treatment for invasive MSSA infections in the target population This is because its clearance is slow in chronic renal failure patients during the replacement phase and it can be administered as a single dose during hemodialysis sessions The most recent French recommendations for cefazolin plasma concentration targets are to maintain the free form concentration at more than 4 times the minimum inhibitory concentration MIC for documented invasive MSSA infections or 40 - 80 mgL total form for probabilistic treatment
However the pharmacokinetics of cefazolin at these high doses have been little studied in renal failure and dialysis patients and dosing recommendations are mainly based on the doses recommended in the Summary of Product Characteristics 500mg at each hemodialysis session up to 2-3g according to later pharmacokinetic and efficacy studies or a fairly similar dosage but adapted to the weight of each patient 20mgkg
To our knowledge there are no pharmacokinetic studies in infected chronic hemodialysis patients using modern assessment tools Given the high interest in this drug in the target population it seems essential to conduct such a study In a second phase a larger study could be conducted to validate the doses proposed in this study
Penicillin M oxacillin and cloxacillin in France is the reference beta-lactam for the treatment of invasive methicillin-sensitive S aureus MSSA infections but large retrospective cohorts comparing penicillin M and cefazolin have shown no prognostic benefit at the expense of more frequent adverse events Whats more its short half-life means that it requires a more time-consuming hemodialysis protocol Cefazolin is therefore the preferred treatment for invasive MSSA infections in the target population This is because its clearance is slow in chronic renal failure patients during the replacement phase and it can be administered as a single dose during hemodialysis sessions The most recent French recommendations for cefazolin plasma concentration targets are to maintain the free form concentration at more than 4 times the minimum inhibitory concentration MIC for documented invasive MSSA infections or 40 - 80 mgL total form for probabilistic treatment
However the pharmacokinetics of cefazolin at these high doses have been little studied in renal failure and dialysis patients and dosing recommendations are mainly based on the doses recommended in the Summary of Product Characteristics 500mg at each hemodialysis session up to 2-3g according to later pharmacokinetic and efficacy studies or a fairly similar dosage but adapted to the weight of each patient 20mgkg
To our knowledge there are no pharmacokinetic studies in infected chronic hemodialysis patients using modern assessment tools Given the high interest in this drug in the target population it seems essential to conduct such a study In a second phase a larger study could be conducted to validate the doses proposed in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EuCT number | OTHER | 2023-506734-73-00 | None |