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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05474118

Acronym

CEFASTA

Enrollment

192

Registered

2022-07-26

Start date

2020-02-05

Completion date

2022-03-31

Last updated

2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocarditis, Infectious Disease

Keywords

cefazolin

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
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.
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.

Countries

France

Outcome results