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

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

Study Overview

• Status: Completed
• Conditions: Infectious Disease; Endocarditis

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 Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• France
  • Metz-Tessy, France, 74374
    • Centre Hospitalier Annecy Genevois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 10 (End of antibiotic treatment according to national recommendations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of clinical and biological tolerance	Occurrence of adverse events such as: acute renal failure, coagulation disorder, cytolysis	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.	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.	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.	10 days (during the antibiotic treatment period)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois
• Investigators: Principal Investigator: Mylène Maillet, CH Annecy Genevois

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: cefazolin
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Infections; Communicable Diseases; Endocarditis, Bacterial; Endocarditis
• Other Study ID Numbers: 18-45b

Drug and device information, study documents

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