Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

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

Study Overview

• Status: Unknown
• Conditions: Bone and Joint Infection; Dactinomycin Adverse Reaction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Eugenie Mabrut, CRA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Anticipated): January 20, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Adverse event; Daptomycin; Bone and joint infection; Eosinophilic pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Pneumonia; Pulmonary Eosinophilia; Anti-Infective Agents; Anti-Bacterial Agents; Daptomycin
• Other Study ID Numbers: 19-283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No