Population Pharmacokinetic Analysis of Daptomycin in Patients With Osteoarticular Infections

NCT ID: NCT03134521

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Infection Joint Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tristan Ferry

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon - Hopital de la Croix Rousse

References

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Tuloup V, Millet A, Taricco A, Parant F, Ferry T, Goutelle S. Evaluation of Limited Sampling Strategies for Bayesian Estimation of Daptomycin Area Under the Concentration-Time Curve: A Short Communication. Ther Drug Monit. 2023 Aug 1;45(4):562-565. doi: 10.1097/FTD.0000000000001070. Epub 2023 Jan 2.

Reference Type DERIVED
PMID: 36728573 (View on PubMed)

Other Identifiers

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69HCL17_0182

Identifier Type: -

Identifier Source: org_study_id

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