Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

NCT ID: NCT04933344

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Dactinomycin Adverse Reaction Bone and Joint Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

patients having had BJI or PJI treated with daptomycin

Intervention Type OTHER

patients having had BJI or PJI treated with daptomycin who developped an adverse event : eosinophilic pneumonia and/or elevation of CPK

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Tristan Ferry, Md,PhD

Role: CONTACT

04 26 73 29 38

Eugenie Mabrut, CRA

Role: CONTACT

04 26 73 29 38

Facility Contacts

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Eugenie Mabrut, CRA

Role: primary

04 26 73 29 38

Related Links

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Other Identifiers

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397

Identifier Type: -

Identifier Source: org_study_id

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