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Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery (SREENSTAPH2)

Primary Purpose

Staphylococcal Infections

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Staphylococcus aureus carriage
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Staphylococcal Infections focused on measuring staphylococcal infections, nasal carriage, nasal cavity, Staphylococcus aureus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing otorhinolaryngologic surgery, unknown Staphylococcus aureus carriage state
  • Patient affiliated to French Social Security
  • Written consent

Exclusion Criteria:

  • Antibiotherapy or infectious episode during the month prior enrollment
  • coagulation disorder
  • neoplasia of the nasal cavity

Sites / Locations

  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient undergoing otorhinolaryngologic surgery

Arm Description

Staphylococcus aureus carriage is measured in the vestibulum nasi and posterior nasal cavity. Posterior nasal cavity is measured during endoscopic procedure.

Outcomes

Primary Outcome Measures

number of patients with staphylococcus aureus carriage in the posterior nasal cavity

Secondary Outcome Measures

number of patients with staphylococcus aureus carriage in the vestibulum nasi

Full Information

First Posted
November 2, 2015
Last Updated
January 26, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02595112
Brief Title
Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery
Acronym
SREENSTAPH2
Official Title
Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery. A Monocentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 4, 2016 (Actual)
Primary Completion Date
September 4, 2017 (Actual)
Study Completion Date
September 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium. Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. This study is aimed at evaluating the relationship between Staphylococcus aureus strains colonizing the vestibulum nasi, the sphenoethmoidal recess and the nasopharynx.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections
Keywords
staphylococcal infections, nasal carriage, nasal cavity, Staphylococcus aureus

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient undergoing otorhinolaryngologic surgery
Arm Type
Experimental
Arm Description
Staphylococcus aureus carriage is measured in the vestibulum nasi and posterior nasal cavity. Posterior nasal cavity is measured during endoscopic procedure.
Intervention Type
Other
Intervention Name(s)
Staphylococcus aureus carriage
Intervention Description
Vestibulum nasi and posterior nasal cavity sampling with swabs and posterior nasal cavity sampling by endoscopic procedure during otorhinolaryngologic surgery
Primary Outcome Measure Information:
Title
number of patients with staphylococcus aureus carriage in the posterior nasal cavity
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
number of patients with staphylococcus aureus carriage in the vestibulum nasi
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing otorhinolaryngologic surgery, unknown Staphylococcus aureus carriage state Patient affiliated to French Social Security Written consent Exclusion Criteria: Antibiotherapy or infectious episode during the month prior enrollment coagulation disorder neoplasia of the nasal cavity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Verhoeven
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery

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