NCT03869255

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 11, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 21, 2019

Last Update Submit

March 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of patietns with specific Clinical and demographic data associated with nasal carrying of SA ST398

    One day

  • Number of patients with SA ST398 positive nasal swab to seven days of hospitalization

    7 days

  • Number of virulence gene in SA ST 398 strains

    One day

Study Arms (2)

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

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

Interventions

Nasal swabPROCEDURE

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 patientsHospitalized patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • None
  • For hospitalized patients :
  • age ≥ 18 years old
  • hospitalization in one of the services participating in the study
  • no refusal of the person
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal swab

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

March 11, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2020

Study Completion

September 1, 2020

Last Updated

March 11, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations