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

NCT05474118 | Completed

• 1 other identifier: 18-45b
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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

Conditions

Infectious Disease; Endocarditis

Keywords

cefazolin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of clinical and biological tolerance

  10 days (Occurrence of adverse events during the antibiotic treatment period)

• Description of clinical predictive factors of failure

  10 days (during the antibiotic treatment period)

• Description of microbiological predictive factors of failure

  10 days (during the antibiotic treatment period)

• Description of ultrasound predictive factors of failure

  10 days (during the antibiotic treatment period)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (1)

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74374, France

Location

MeSH Terms

Conditions

Communicable Diseases; Endocarditis

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Mylène Maillet

  CH Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: February 5, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 26, 2022

Record last verified: 2021-09

Locations

FR (1)