Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M

Completed

• Conditions: Infectious Disease; Endocarditis

• Registration Number: NCT05474118
• Lead Sponsor: Centre Hospitalier Annecy Genevois

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-02-05
• Status Verified: 2021-09
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-21
• Last Update Submitted: 2022-07-21
• Study First Posted: 2022-07-26
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Definite infective endocarditis according to Duke criteria
• Documented SAMS or meticillin-sensitive SCN
• Treated with Cefazolin or Penicillin M for at least 10 consecutive days
• Treatment initiated between 01/01/2014 and 12/31/2018

Exclusion Criteria

• Patients under 18 years old
• Patients under 18 years old.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Day 10 (End of antibiotic treatment according to national recommendations	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

Secondary Outcome Measures

Name	Time	Method
Description of clinical predictive factors of failure	10 days (during the antibiotic treatment period)	Collection of clinical data in order to identify certain predictive factors of failure using directed acyclic graph.
Assessment of clinical and biological tolerance	10 days (Occurrence of adverse events during the antibiotic treatment period)	Occurrence of adverse events such as: acute renal failure, coagulation disorder, cytolysis
Description of ultrasound predictive factors of failure	10 days (during the antibiotic treatment period)	Collection of ultrasound data in order to identify certain predictive factors of failure using directed acyclic graph.
Description of microbiological predictive factors of failure	10 days (during the antibiotic treatment period)	Collection of microbiological data in order to identify certain predictive factors of failure using directed acyclic graph.

Trial Locations

Locations (1)

Centre Hospitalier Annecy Genevois; 🇫🇷 Metz-Tessy, France