Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03134521
Status:
UNKNOWN
Last Update Posted:
2017-05-11
First Post:
2017-03-29
Brief Title:
Population Pharmacokinetic Analysis of Daptomycin in Patients With Osteoarticular Infections
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Population Pharmacokinetic Analysis of Daptomycin in Patients With Osteoarticular Infections
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
Daptomycin is validated as a treatment of bone and joint infections by the Infectious Disease Society of America However most of studies did not investigate daptomycin pharmacokinetics in this indication while it is known that efficacy and toxicity concentration studies show a close therapeutic margin
Evaluation of P-Glycoprotein P-gp a transmembrane transport protein has demonstrated its influence on the concentration and intracellular activity of daptomycin Recent work has linked the genetic polymorphism of P-gp to the pharmacokinetics of daptomycin which may explain inter-individual variability but requires further explorations Previous studies demonstrated existence of interindividual variabilities as sex renal function and p-glycoprotein polymorphism couple with an intraindividual variabilities unexplained yet
A population approach will be used to determinate the pharmacokinetics factors their intra and interindividual variabilities the parameters associated to those variabilities as the p glycoprotein
The investigators goal is to evaluate different posology and to try to increase daptomycin efficacy and security in bone and joint infection
Evaluation of P-Glycoprotein P-gp a transmembrane transport protein has demonstrated its influence on the concentration and intracellular activity of daptomycin Recent work has linked the genetic polymorphism of P-gp to the pharmacokinetics of daptomycin which may explain inter-individual variability but requires further explorations Previous studies demonstrated existence of interindividual variabilities as sex renal function and p-glycoprotein polymorphism couple with an intraindividual variabilities unexplained yet
A population approach will be used to determinate the pharmacokinetics factors their intra and interindividual variabilities the parameters associated to those variabilities as the p glycoprotein
The investigators goal is to evaluate different posology and to try to increase daptomycin efficacy and security in bone and joint infection
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