Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

• Conditions: Dactinomycin Adverse Reaction; Bone and Joint Infection

• Registration Number: NCT04933344
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

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 Timeline

• Study Start: 2021-06-15
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-21
• Primary Completion: 2022-03-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France