PKTOXDAP: Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04933344

Collaborator

(none)

1,130

Enrollment

Location

12.5

Anticipated Duration (Months)

90.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dactinomycin Adverse Reaction Bone and Joint Infection	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 Design

Study Type:

Observational

Anticipated Enrollment :

1130 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Actual Study Start Date :

Jun 15, 2021

Actual Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

rate of patients having had a PJI or BJI treated by daptomycin [between 2010 and 2020]
proportion of patients treated by daptomycin
description of BJI/PJI [between 2010 and 2020]
type of BJI or PJI
description of patients [between 2010 and 2020]
comorbidites
description of adverse event [between 2010 and 2020]
type of adverse event
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 : dosage of daptomycine [between 2010 and 2020]
description of the use of daptomycine : dosage
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)