An observational study in Infectious Disease and Endocarditis, sponsored by Centre Hospitalier Annecy Genevois. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Centre Hospitalier Annecy Genevois · Observational
Retrospective, regional, multicenter study (including the Annecy-Genevois Hospital Center, the Chambéry Métropole Savoie Hospital Center, and the Grenoble University Hospital Center), comparing a cohort of patients treated with Cefazolin with a cohort of patients treated with Penicillin M
The use of Cefazolin for the treatment of infective endocarditis caused by Staphylococcus meti - S has become commonplace in France following the stockout of injectable Penicillin M, the reference treatment, which occurred during 2016.
There is currently no clinical data to prejudge the efficacy of Cefazolin in the context of high inoculum, such as in the treatment of infective endocarditis.
On the other hand, recent data have described a better tolerance profile for Cefazolin than for Penicillin M.
The objective of this study is to compare the efficacy and safety of Cefazolin with that of Penicillin M in the management of methicillin-susceptible staphylococcal endocarditis, through the analysis of two retrospective cohorts.
626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.
This study's enrollment of 192 is close to the median of 200 across 228 observational studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Centre Hospitalier Annecy Genevois is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
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Patients included in the study are adults older than 18 years of age, who were treated between 01/01/2014 and 12/31/2018 for definite infective endocarditis according to Duke criteria. The infection must have been documented with Staphylococcus Meti -S, on native valve or device, and treated with Cefazolin or Penicillin M for at least 10 consecutive days.
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Exclusion Criteria:
Comparison of the efficacy of Cefazolin in the treatment of Staphylococcus meti -S infective endocarditis, with that of Penicillin M, by observing the rate of death, relapse of infective endocarditis and occurence of embolic event.
The primary outcome is management failure, a composite outcome defined by the existence of at least one of the following: * Death before the end of treatment * Relapse of infective endocarditis, with the same germ, within 3 months of the end of antibiotic therapy * Occurrence of embolic event after antibiotic therapy
Time frame: Day 10 (End of antibiotic treatment according to national recommendations
Assessment of clinical and biological tolerance
Occurrence of adverse events such as: acute renal failure, coagulation disorder, cytolysis
Time frame: 10 days (Occurrence of adverse events during the antibiotic treatment period)
Description of clinical predictive factors of failure
Collection of clinical data in order to identify certain predictive factors of failure using directed acyclic graph.
Time frame: 10 days (during the antibiotic treatment period)
Description of microbiological predictive factors of failure
Collection of microbiological data in order to identify certain predictive factors of failure using directed acyclic graph.
Time frame: 10 days (during the antibiotic treatment period)
Description of ultrasound predictive factors of failure
Collection of ultrasound data in order to identify certain predictive factors of failure using directed acyclic graph.
Time frame: 10 days (during the antibiotic treatment period)
Ran from Feb 2020 to primary completion in Mar 2022, 25 months.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Annecy Genevois