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Completed

NCT Number: NCT05474118

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

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

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Key information

Conditions

Infectious Disease Cardiovascular Diseases Communicable Diseases Disease Attributes Endocarditis Heart Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74374, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    Time frame: 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 outcomes

  1. Assessment of clinical and biological tolerance

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

    Occurrence of adverse events such as: acute renal failure, coagulation disorder, cytolysis

  2. Description of clinical predictive factors of failure

    Time frame: 10 days (during the antibiotic treatment period)

    Collection of clinical data in order to identify certain predictive factors of failure using directed acyclic graph.

  3. Description of microbiological predictive factors of failure

    Time frame: 10 days (during the antibiotic treatment period)

    Collection of microbiological data in order to identify certain predictive factors of failure using directed acyclic graph.

  4. Description of ultrasound predictive factors of failure

    Time frame: 10 days (during the antibiotic treatment period)

    Collection of ultrasound data in order to identify certain predictive factors of failure using directed acyclic graph.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Annecy Genevois

Other

Registry information

Acronym: CEFASTA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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