Antistaphylococcal Betalactam and Emergence of Resistance

Bacterial Resistance Clinical Trial

— CePasR  

Official title:

Impact of Antistaphylococcal Penicillins and Cefazolin on the Emergence of Resistance in French Hospitals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05939479
• Other study ID #: 2023PI051
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Antistaphylococcal penicillins are recommanded as first-line agent in methicillin-suceptible Staphylococcus aureus bacteraemia. Several studies in progress are investigating the efficacy and safety of cefazolin compared with antistaphylococcal penicillins. Cefazolin has broader spectrum than antistaphylococcal penicillins. The hypothesis of this project is that cefazoline could be responsible for a higher rate of bacterial resistance. The aim is to study the association between the emergence of bacterial resistance and the consumption of cefazolin and antistaphylococcal penicillins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 644
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: French hospitals which have collected their consumption and resistance data on the French national database named CONSORES (From 2019 to 2022)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Bacterial Resistance
• Hypersensitivity
• Methicillin-Sensitive Staphylococcus Aureus Infection
• Staphylococcal Infections

Locations

Country	Name	City	State
France	Lefevre	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between the cefazolin/antistaphylococcal penicillins consumptions and the resistant bacteria emergence	The total consumption of antibiotics (expressed as number of Defined Daily Doses (DDD) per 1000 inhabitants per day) will be correlate with the resistant bacteria emergence (only incidence for each bacterial strain)	Between the first january 2018 and the 31st december 2022
Secondary	Factors associated with the emergence of resistant bacteria	Factors associated with the emergence of resistant bacteria will be described by a Cox model: hospital size (number of beds), location in France, activities (intensive care, surgery, etc.), type of antibiotics and intensity of consumption expressed in number of defined daily doses (DDD).	Between the first january 2018 and the 31st december 2022
Secondary	Factors associated with the consumption of antibiotics	Factors associated with the emergence of resistant bacteria will be described by a Cox model: hospital size (number of beds), location in France, activities (intensive care, surgery, etc.) and type of bacterial strain indentified (resistant or not).	Between the first january 2018 and the 31st december 2022
Secondary	Evolution of resistance in French hospitals	For each year, bacterial resistance will be described, in France and in each hospital, in the form of a quantitative variable: number of resistant bacterial strains isolated for each year (number of resistant strains / total number of strains).	Between the first january 2018 and the 31st december 2022
Secondary	Evolution of antibiotics consumption in French hospitals	For each year, antibiotic consumption will be described, in France and in each hospital, in the form of a quantitative variable (expressed as number of Defined Daily Doses (DDD) per 1000 inhabitants per day)	Between the first january 2018 and the 31st december 2022