Infectious DiseaseCEFASTANCT05474118
Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M
An observational study of Infectious Disease and Endocarditis, run by Centre Hospitalier Annecy Genevois at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease, Endocarditis
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2020to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients under 18 years old
- Patients under 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Infectious Disease, Endocarditis
- Keywords
- cefazolin
- Medical subject headings
- Communicable Diseases, Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 10 (End of antibiotic treatment according to national recommendations
Secondary outcomes (4)
Assessment of clinical and biological tolerance
Occurrence of adverse events such as: acute renal failure, coagulation disorder, cytolysis
Measured: 10 days (Occurrence of adverse events during the antibiotic treatment period)
Description of clinical predictive factors of failure
Collection of clinical data in order to identify certain predictive factors of failure using directed acyclic graph.
Measured: 10 days (during the antibiotic treatment period)
Description of microbiological predictive factors of failure
Collection of microbiological data in order to identify certain predictive factors of failure using directed acyclic graph.
Measured: 10 days (during the antibiotic treatment period)
Description of ultrasound predictive factors of failure
Collection of ultrasound data in order to identify certain predictive factors of failure using directed acyclic graph.
Measured: 10 days (during the antibiotic treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start5 Feb 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mylène Maillet, Principal investigator, CH Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474118
- Sponsor's protocol ID
- 18-45b
- Acronym
- CEFASTA
- Status last verified
- Sep 2021
- First submitted
- 19 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M
- ClinicalTrials.gov ID
- NCT05474118
- Acronym / sponsor ID
- CEFASTA / 18-45b
- Conditions
- Infectious Disease, Endocarditis
- Keywords
- cefazolin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under 18 years old
- Patients under 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Assessment of clinical and biological tolerance
Time frame: 10 days (Occurrence of adverse events during the antibiotic treatment period)
Description of clinical predictive factors of failure
Time frame: 10 days (during the antibiotic treatment period)
Description of microbiological predictive factors of failure
Time frame: 10 days (during the antibiotic treatment period)
Description of ultrasound predictive factors of failure
Time frame: 10 days (during the antibiotic treatment period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mylène Maillet principal investigator
CH Annecy Genevois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease and Endocarditis, run by Centre Hospitalier Annecy Genevois at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 10 (End of antibiotic treatment according to national recommendations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.