NCT04414137

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

May 12, 2020

Last Update Submit

November 6, 2020

Conditions

Dactinomycin Adverse ReactionBone and Joint Infection

Keywords

Eosinophilic pneumoniaDaptomycinBone and joint infectionAdverse event

Outcome Measures

Primary Outcomes (7)

  • description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin

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

    2 months

  • description patients having eosinophilic pneumonia due to daptomycin

    description of the patients (average age, medical background)

    2 months

  • rate of eosinophilic pneumonia due to daptomycin in osteoarticular infection: the adverse event

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

    6 months

  • Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine

    description of the use of daptomycine : dosage

    6 months

  • Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine

    description of the use of daptomycine : duration

    6 months

  • Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance

    mean daptomycine plasma clearance (unit, liters per hour)

    6 months

  • Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution

    mean daptomycine volume of distribution (unit, liters)

    6 months

Study Arms (1)

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

Interventions

Description of eosinophilic pneumonia due to daptomycineOTHER

Description of eosinophilic pneumonia in patients treated by daptomycin for an osteoarticular infection

Eosinophilic pneumonia on daptomycin

Eligibility Criteria

Age15 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI) treated at the CRIOAc Lyon

You may qualify if:

  • patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

Related Links

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Eugénie Mabrut, CRA

CONTACT

04 26 73 29 38eugenie.mabrut@chu-lyon.fr

Tristan Ferry, Md,PhD

CONTACT

04 26 73 29 38tristan.ferry@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

June 4, 2020

Study Start

February 19, 2019

Primary Completion

January 20, 2021

Study Completion

September 1, 2021

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

FR(1)