## Protocol Section
### Identification Module
**NCT ID:** NCT05939479

**Acronym:** CePasR

**Brief Title:** Antistaphylococcal Betalactam and Emergence of Resistance

**Official Title:** Impact of Antistaphylococcal Penicillins and Cefazolin on the Emergence of Resistance in French Hospitals

#### Organization Study ID Info
**ID:** 2023PI051
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2023-06-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-11

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2023-07-11
**Type:** ACTUAL
**Study First Submit Date:** 2023-06-23
**Study First Submit QC Date:** 2023-07-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Central Hospital, Nancy, France

#### Responsible Party

**Investigator Affiliation:** Central Hospital, Nancy, France

**Investigator Full Name:** LEFEVRE Benjamin

**Investigator Title:** M.D.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Bacterial Resistance

- Methicillin-Sensitive Staphylococcus Aureus Infection

**Keywords:**

- cefazolin

- antistaphylococcal penicillins

- Methicillin-Sensitive Staphylococcus Aureus Infection

- Bacterial Resistance

### Design Module

#### Design Info

**Observational Model:** ECOLOGIC_OR_COMMUNITY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 644

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Association between the cefazolin/antistaphylococcal penicillins consumptions and the resistant bacteria emergence

**Time Frame:** Between the first january 2018 and the 31st december 2022

#### Secondary Outcomes

**Description:** 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).

**Measure:** Factors associated with the emergence of resistant bacteria

**Time Frame:** Between the first january 2018 and the 31st december 2022

**Description:** 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).

**Measure:** Factors associated with the consumption of antibiotics

**Time Frame:** Between the first january 2018 and the 31st december 2022

**Description:** 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).

**Measure:** Evolution of resistance in French hospitals

**Time Frame:** Between the first january 2018 and the 31st december 2022

**Description:** 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)

**Measure:** Evolution of antibiotics consumption in French hospitals

**Time Frame:** Between the first january 2018 and the 31st december 2022

### Eligibility Module

**Eligibility Criteria:** 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

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** All the patients hospitalized in included French hospitals

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nancy

**Country:** France

**Facility:** Lefevre

**State:** Lorraine

**Zip:** 54500

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000007154

- Term: Immune System Diseases

- ID: D000016908

- Term: Gram-Positive Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: HIGH

- As Found: Sensitive

- ID: M15996

- Name: Staphylococcal Infections

- Relevance: HIGH

- As Found: Staphylococcus Aureus Infection

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19252

- Name: Gram-Positive Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013203

- Term: Staphylococcal Infections

- ID: D000006967

- Term: Hypersensitivity

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5687

- Name: Cefazolin

- Relevance: LOW

- As Found: Unknown

- ID: M13317

- Name: Penicillins

- Relevance: LOW

- As Found: Unknown

- ID: M25772

- Name: beta-Lactams

- Relevance: LOW

- As Found: Unknown

- ID: M11688

- Name: Methicillin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
