Population Pharmacokinetic Analysis of Daptomycin in Patients With Osteoarticular Infections
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 investigator's goal is to evaluate different posology and to try to increase daptomycin efficacy and security in bone and joint infection.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
Patients
- having had a bone or joint infection, with or without implant,
- having an antibiotherapy with daptomycin between December 2012 and December 2016 at the Croix-Rousse hospital
- are at least 18 years old
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Peak plasma concentration (Cmax)
Tidsram: Month 6
|
Month 6
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Area under the concentration-time curve
Tidsram: up to 6 months
|
up to 6 months
|
|
|
typical daptomycin clearance and volume of distribution in the population
Tidsram: Month 6
|
Month 6
|
|
|
Mean daptomycine plasma clearance
Tidsram: Month 6
|
(unit, liters per hour)
|
Month 6
|
|
Mean daptomycine volume of distribution
Tidsram: Month 6
|
(unit, liters)
|
Month 6
|
|
Inter-individual coefficient of variation of daptomycin clearance
Tidsram: Month 6
|
(unit, %)
|
Month 6
|
|
Inter-individual coefficient of variation of daptomycin volume of distribution
Tidsram: Month 6
|
(unit, %)
|
Month 6
|
|
Intra-individual coefficient of variation of daptomycin clearance
Tidsram: Month 6
|
(unit, %)
|
Month 6
|
|
Intra-individual coefficient of variation of daptomycin volume of distribution
Tidsram: Month 6
|
(unit, %)
|
Month 6
|
|
influence of demographic and biological covariates on pharmacokinetics (e.g. : renal function, gender)
Tidsram: Month 6
|
the influence of demographic and biological covariates on pharmacokinetics will be assessed statistically by using the Akaike Information Criterion (AIC, no unit).
AIC = -2xLL + 2P, where LL is the log-likelihood computed by the population algorithm and P is the number of parameters in the model.
A covariate will be considered as significant if it is associated with a decrease in the AIC value compared with the base model without covariate.
|
Month 6
|
|
influence of p-glycoprotein pharmacogenetics on daptomycin pharmacokinetics
Tidsram: Month 6
|
the influence of P-glycoprotein pharmacogenetics on pharmacokinetics will be assessed statistically by using the Akaike Information Criterion (AIC, no unit).
AIC = -2xLL + 2P, where LL is the log-likelihood computed by the population algorithm and P is the number of parameters in the model.
The P-glycoprotein genotype will be considered as significant if it is associated with a decrease in the AIC value compared with the base model without covariate.
|
Month 6
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tristan Ferry, Hospices Civils de Lyon - Hôpital de la Croix Rousse
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 69HCL17_0182
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