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

Infectious Disease Clinical Trial

— CEFASTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05474118
• Other study ID #: 18-45b
• Status: Completed
• Start date: February 5, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2021
• Source: Centre Hospitalier Annecy Genevois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Endocarditis
• Endocarditis, Bacterial
• Infections
• Infectious Disease

Locations

Country	Name	City	State
France	Centre Hospitalier Annecy Genevois	Metz-Tessy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)