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

January 26, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Chu Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient undergoing otorhinolaryngologic surgery
Staphylococcus aureus carriage is measured in the vestibulum nasi and posterior nasal cavity. Posterior nasal cavity is measured during endoscopic procedure.
Other: Staphylococcus aureus carriage
Vestibulum nasi and posterior nasal cavity sampling with swabs and posterior nasal cavity sampling by endoscopic procedure during otorhinolaryngologic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients with staphylococcus aureus carriage in the posterior nasal cavity
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
number of patients with staphylococcus aureus carriage in the vestibulum nasi
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Paul Verhoeven, Chu Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2016

Primary Completion (Actual)

September 4, 2017

Study Completion (Actual)

September 5, 2017

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508154
  • 2015-A01620-49 (Other Identifier: ANSM)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Staphylococcal Infections

Clinical Trials on Staphylococcus aureus carriage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe