Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495697
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-04
Brief Title:
Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia - Single-center Retrospective Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
DOSESACLOXA
Brief Summary:
The treatment of Methicillin-sensitive Staphylococcus aureus bacteremia is based on the first-line use of cefazolin or M penicillins oxacillin and cloxacillin The use of the latter is recommended at high doses 150-200 mgkg24h In a study on infectious endocarditis 52 of 56 patients with staphylococcal endocarditis treated with cloxacillin were overdosed with the recommended doses Although the main mechanism of renal toxicity described for M penicillins is immunoallergic a frequent overdose is observed in cases of acute renal failure with M penicillins There is also a significant association between overdose and risk of neurological toxicity The currently recommended treatment duration is a minimum of 14 days of IV treatment from the first negative blood culture which leaves room for carrying out a plasma assay and possible dosage adjustment subsequently
Overdose is a risk factor for nephrotoxicity and neurotoxicity Plasma level could be predictive of clinical success Systematic plasma dosing would reduce the risk of toxicity and improve the clinical cure rate
Overdose is a risk factor for nephrotoxicity and neurotoxicity Plasma level could be predictive of clinical success Systematic plasma dosing would reduce the risk of toxicity and improve the clinical cure rate
Detailed Description:
None
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