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NCT04933344 Clinical Trial

Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Bone and Joint Infection Clinical Trial

— PKTOXDAP  

Official title:
Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04933344
Other study ID # 397
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 15, 2021
Est. completion date July 1, 2022

Study information
Verified date May 2022
Source Hospices Civils de Lyon
Contact Tristan Ferry, Md,PhD
Phone 04 26 73 29 38
Email tristan.ferry@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1130
Est. completion date July 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

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