Nasal Carrying by Staphylococcus Aureus ST398 Strains in Community and Hospital Settings (CONASA 398)

The aim of this study was to compare the prevalence of nasal carrying of SA ST398 strains in community and hospital settings, identify the factors associated with colonization of SA ST398, determine the distribution of imported and acquired cases among SA ST398 hospital cases and characterize the genetic structure of the ST398 SA population involved in colonization.

Study Overview

• Status: Unknown
• Conditions: Staphylococcus Aureus Nasal Carriage
• Intervention / Treatment: Procedure: Nasal swab

Detailed Description

Staphylococcus aureus (SA) is a ubiquitous bacterium, part of the human commensal flora. The mucosa of the anterior nasal cavities represents the preferred site of colonization of SA. The SA ST398 clone, belonging to CC 398, was initially described as a zoonotic agent initially identified in France and the Netherlands. In fact, ST398 strains are separated into two distinct populations: a methicillin-resistant SA population (SAMR) with notion of contact with animals and a more virulent methicillin-sensitive SA population (SAMS) than its counterpart, isolated from serious human infections and without notion of exposure to farm animals. Recently, we have shown that, in SA bacteremia, all strains of SA ST398 are sensitive to methicillin and that the prevalence of ST398 among all SAMS responsible for bacteremia at Besançon University Hospital increased between 2009 and 2014, increased from 4 to 15%. However, we were unable to study nasal colonization to support the mode of acquisition of SA ST398 (community vs. healthcare acquisition).

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • CHU de Besancon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For community patients : All patients presenting for blood donation will be included For hospitalized patients, all patients hospitalized less than 48h in a service participating to the study will be enrolled

Description

For community patients :

Inclusion Criteria:

• the selection criteria for blood donation
• age ≥ 18 years old
• No refusal of the person

Exclusion Criteria:

• None

For hospitalized patients :

Inclusion Criteria:

• age ≥ 18 years old
• hospitalization in one of the services participating in the study
• no refusal of the person

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hospitalized patients; Within 48 hours of admission to participating departments, all patiens will be included. A nasal swab will be performed within the first 48 hours and on the 7th day.	Procedure: Nasal swab; In hospitalized patiens, a nasal swab will be performed within the first 48 hours and on the 7th day. In community patient, only one swab will be performed
Community patients; People coming to donate blood in "Etablissement Français du Sang" will be included and a nasal swab will be performed	Procedure: Nasal swab; In hospitalized patiens, a nasal swab will be performed within the first 48 hours and on the 7th day. In community patient, only one swab will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients nasal carrying of SA ST398 strains in community and hospital settings	Number of patients with SA ST398 positive nasal swab in community will be compared with number of patients with SA ST398 positive nasal swab in hospital	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patietns with specific Clinical and demographic data associated with nasal carrying of SA ST398	Clinical and demographic (sex, age, gender, comorbidities, tabaco...) data will be compared between patients with SA ST398 positive nasal swab and SA ST398 negative nasal swab	One day
Number of patients with SA ST398 positive nasal swab to seven days of hospitalization	Number of patients with SA ST398 positive nasal swab to seven days of hospitalization will be compared with the number of patients with SA ST398 positive nasal swab within the first 48 hours of hospitalization	7 days
Number of virulence gene in SA ST 398 strains	Presence of virulence gene in SA ST 398 strains	One day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections
• Other Study ID Numbers: API/2018/96

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No