Population Pharmacokinetic Analysis of Daptomycin in Patients With Osteoarticular Infections

NCT03134521 | Unknown

• 1 other identifier: 69HCL17_0182
• Study Type: observational
• Target: 189
• Locations: 0 countries
• Sites: N/A

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 investigator's goal is to evaluate different posology and to try to increase daptomycin efficacy and security in bone and joint infection.

Conditions

Bone Infection; Joint Infection

Keywords

bone and joint infection; daptomycin; population pharmacokinetics; Glycoprotein-P (PgP)

Outcome Measures

Primary Outcomes (1)

• Peak plasma concentration (Cmax)

  Month 6

Secondary Outcomes (10)

• Area under the concentration-time curve

  up to 6 months

• typical daptomycin clearance and volume of distribution in the population

  Month 6

• Mean daptomycine plasma clearance

  Month 6

• Mean daptomycine volume of distribution

  Month 6

• Inter-individual coefficient of variation of daptomycin clearance

  Month 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having bone or joint infection, with or without implant, having an antibiotherapy with daptomycin

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Related Publications (1)

• 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.

  PMID: 36728573 DERIVED

Study Officials

• Tristan Ferry

  Hospices Civils de Lyon - Hopital de la Croix Rousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: May 1, 2017
• Study Start: December 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05