Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections (PKTOXDAP)

the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection

Study Overview

• Status: Recruiting
• Conditions: Bone and Joint Infection; Dactinomycin Adverse Reaction
• Intervention / Treatment: Other: patients having had BJI or PJI treated with daptomycin

Detailed Description

Daptomycin is widely used in osteoarticular infections (IOA), as an alternative to vancomycin, and recommended for this use by various learned societies including the Infectious Diseases Society of America (IDSA) in 2013.

Tolerance to daptomycin is generally favorable, with in particular better renal tolerance than vancomycin. However, two rare and potentially severe side effects have been described with this antibiotics: muscle toxicity and eosinophilic pneumonia.

• Study Type: Observational
• Enrollment (Anticipated): 1130

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients managed at the CRIOAc Lyon who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed

Description

Inclusion Criteria:

• Patients who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed

Exclusion Criteria:

• Patients who objected to participating in the study
• Absence of blood dosage of daptomycin

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients having had BJI or PJI treated with daptomycin; patients having an osteoarticular infection treated with daptomycin and which developped eosinophilic pneumonia or elevation of CPK	Other: patients having had BJI or PJI treated with daptomycin; patients having had BJI or PJI treated with daptomycin who developped an adverse event : eosinophilic pneumonia and/or elevation of CPK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of patients having had a PJI or BJI treated by daptomycin	proportion of patients treated by daptomycin	between 2010 and 2020
description of BJI/PJI	type of BJI or PJI	between 2010 and 2020
description of patients	comorbidites	between 2010 and 2020
description of adverse event	type of adverse event	between 2010 and 2020
rate of patients having had an adverse event	proportion of patients having had an adverse event under daptomycin	between 2010 and 2020
Evalutation of the adverse event due to daptomycin : dosage of daptomycine	description of the use of daptomycine : dosage	between 2010 and 2020
Evalutation of the adverse event due to daptomycin : duration of daptomycine	description of the use of daptomycine : duration	between 2010 and 2020
Evalutation of the adverse event due to daptomycin : daptomycine plasma clearance	mean daptomycine plasma clearance (unit, liters per hour)	between 2010 and 2020
Evalutation of the adverse event due to daptomycin : daptomycine volume distribution	mean daptomycine volume of distribution (unit, liters)	between 2010 and 2020

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2021
• Primary Completion (ACTUAL): March 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (ACTUAL): June 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: bone and joint infection; rhabdomyolysis; daptomycin; adverse event; CPK; Eosinophilic pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious; Anti-Infective Agents; Anti-Bacterial Agents; Daptomycin
• Other Study ID Numbers: 397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No