An observational study in Dactinomycin Adverse Reaction and Bone and Joint Infection, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Hospices Civils de Lyon · Observational
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
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
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 20 is below the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI) treated at the CRIOAc Lyon
Exclusion Criteria:
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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
description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin
description of the BJI/PJI (symptoms, type of evolution, type of implant)
Time frame: 2 months
description patients having eosinophilic pneumonia due to daptomycin
description of the patients (average age, medical background)
Time frame: 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
Time frame: 6 months
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine
description of the use of daptomycine : dosage
Time frame: 6 months
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine
description of the use of daptomycine : duration
Time frame: 6 months
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance
mean daptomycine plasma clearance (unit, liters per hour)
Time frame: 6 months
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution
mean daptomycine volume of distribution (unit, liters)
Time frame: 6 months
Plan to share: Undecided
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon