Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04414137
Collaborator
(none)
20
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30.4
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Study Details

Study Description

Brief Summary

Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.

Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide.

The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future

Condition or Disease Intervention/Treatment Phase
  • Other: Description of eosinophilic pneumonia due to daptomycine

Detailed Description

Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.

The Infectious Diseases Society of America recommends the use of daptomycin 6 mg / kg / day in the second-line treatment of IOA on staphylococcal but also enterococcal prostheses, as an alternative to vancomycin and linezolid.

In case of renal failure, daptomycin is often considered as a good therapeutic alternative to glycopeptides.

Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide. Although a large proportion of cases have been reported in patients receiving daptomycin in unapproved indications, the use of daptomycin in authorized indications has also been associated with this risk.

The dosage of daptomycin makes it possible to evaluate its effectiveness and prevent the occurrence of a overdose, provider of side effects.

The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin
Actual Study Start Date :
Feb 19, 2019
Anticipated Primary Completion Date :
Jan 20, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Eosinophilic pneumonia on daptomycin

patients having an osteoarticular infection treated with daptomycin and which developped eosinophilic pneumonia

Other: Description of eosinophilic pneumonia due to daptomycine
Description of eosinophilic pneumonia in patients treated by daptomycin for an osteoarticular infection

Outcome Measures

Primary Outcome Measures

  1. description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin [2 months]

    description of the BJI/PJI (symptoms, type of evolution, type of implant)

  2. description patients having eosinophilic pneumonia due to daptomycin [2 months]

    description of the patients (average age, medical background)

  3. rate of eosinophilic pneumonia due to daptomycin in osteoarticular infection: the adverse event [6 months]

    number of cases and description of the adverse event as assessed by CTCAE v4.0

  4. Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine [6 months]

    description of the use of daptomycine : dosage

  5. Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine [6 months]

    description of the use of daptomycine : duration

  6. Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance [6 months]

    mean daptomycine plasma clearance (unit, liters per hour)

  7. Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution [6 months]

    mean daptomycine volume of distribution (unit, liters)

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI)
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon Lyon France 69004

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04414137
Other Study ID Numbers:
  • 19-283
First Posted:
Jun 4, 2020
Last Update Posted:
Nov 9, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2020