Clinical trial NCT05474118: Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M
Official title: Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Disease
Endocarditis
Keywords: cefazolin
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Day 10 (End of antibiotic treatment according to national recommendations
Secondary outcomes:
measure: Assessment of clinical and biological tolerance
timeFrame: 10 days (Occurrence of adverse events during the antibiotic treatment period)
measure: Description of clinical predictive factors of failure
timeFrame: 10 days (during the antibiotic treatment period)
measure: Description of microbiological predictive factors of failure
timeFrame: 10 days (during the antibiotic treatment period)
measure: Description of ultrasound predictive factors of failure
timeFrame: 10 days (during the antibiotic treatment period)
Other outcomes:
Locations:
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
Study officials:
affiliation: CH Annecy Genevois
name: Mylène Maillet
role: PRINCIPAL_INVESTIGATOR
References: