Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections
PKTOXDAP
1 other identifier
observational
1,130
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMay 6, 2022
May 1, 2022
9 months
June 15, 2021
May 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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
Study Arms (1)
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
Interventions
patients having had BJI or PJI treated with daptomycin who developped an adverse event : eosinophilic pneumonia and/or elevation of CPK
Eligibility Criteria
Patients managed at the CRIOAc Lyon who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed
You may qualify if:
- Patients who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed
You may not qualify if:
- Patients who objected to participating in the study
- Absence of blood dosage of daptomycin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Lyon, 69004, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2021
First Posted
June 21, 2021
Study Start
June 15, 2021
Primary Completion
March 1, 2022
Study Completion
July 1, 2022
Last Updated
May 6, 2022
Record last verified: 2022-05