Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

Bone and Joint Infection Clinical Trial

Official title:

Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414137
• Other study ID #: 19-283
• Status: Recruiting
• Start date: February 19, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2020
• Source: Hospices Civils de Lyon
• Contact: Eugénie Mabrut, CRA
• Phone: 04 26 73 29 38
• Email: eugenie.mabrut[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2021
• Est. primary completion date: January 20, 2021
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Bone and Joint Infection
• Dactinomycin Adverse Reaction
• Pneumonia
• Pulmonary Eosinophilia

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	description patients having eosinophilic pneumonia due to daptomycin	description of the patients (average age, medical background)	2 months
Primary	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
Primary	Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine	description of the use of daptomycine : dosage	6 months
Primary	Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine	description of the use of daptomycine : duration	6 months
Primary	Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance	mean daptomycine plasma clearance (unit, liters per hour)	6 months
Primary	Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution	mean daptomycine volume of distribution (unit, liters)	6 months

External Links

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