Nasal Carrying by Staphylococcus Aureus ST398 Strains in Community and Hospital Settings

Staphylococcus Aureus Nasal Carriage Clinical Trial

— CONASA 398  

Official title:

Nasal Carrying by Staphylococcus Aureus ST398 Strains in Community and Hospital Settings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03869255
• Other study ID #: API/2018/96
• Status: Not yet recruiting
• Start date: April 2019
• Est. completion date: September 2020

Study information

• Verified date: February 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: September 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

For community patients :

Inclusion Criteria:

• the selection criteria for blood donation

• age = 18 years old

• No refusal of the person

Exclusion Criteria:

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:

Related Conditions & MeSH terms

• Staphylococcus Aureus Nasal Carriage

Intervention

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

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of virulence gene in SA ST 398 strains	Presence of virulence gene in SA ST 398 strains	One day