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Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04933344
Acronym
PKTOXDAP
Enrollment
1130
Registered
2021-06-21
Start date
2021-06-15
Completion date
2022-07-01
Last updated
2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone and Joint Infection, Dactinomycin Adverse Reaction

Keywords

bone and joint infection, adverse event, daptomycin, Eosinophilic pneumonia, CPK, rhabdomyolysis

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.

Interventions

OTHERpatients 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
rate of patients having had a PJI or BJI treated by daptomycinbetween 2010 and 2020proportion of patients treated by daptomycin
description of BJI/PJIbetween 2010 and 2020type of BJI or PJI
description of patientsbetween 2010 and 2020comorbidites
description of adverse eventbetween 2010 and 2020type of adverse event
rate of patients having had an adverse eventbetween 2010 and 2020proportion of patients having had an adverse event under daptomycin
Evalutation of the adverse event due to daptomycin : dosage of daptomycinebetween 2010 and 2020description of the use of daptomycine : dosage
Evalutation of the adverse event due to daptomycin : duration of daptomycinebetween 2010 and 2020description of the use of daptomycine : duration
Evalutation of the adverse event due to daptomycin : daptomycine plasma clearancebetween 2010 and 2020mean daptomycine plasma clearance (unit, liters per hour)
Evalutation of the adverse event due to daptomycin : daptomycine volume distributionbetween 2010 and 2020mean daptomycine volume of distribution (unit, liters)

Countries

France

Contacts

Primary ContactTristan Ferry, Md,PhD
tristan.ferry@chu-lyon.fr04 26 73 29 38
Backup ContactEugenie Mabrut, CRA
eugenie.mabrut@chu-lyon.fr04 26 73 29 38

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026