NCT02595112

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

November 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 4, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
Last Updated

January 30, 2018

Status Verified

December 1, 2017

Enrollment Period

1.6 years

First QC Date

November 2, 2015

Last Update Submit

January 26, 2018

Conditions

Staphylococcal Infections

Keywords

staphylococcal infectionsnasal carriagenasal cavityStaphylococcus aureus

Outcome Measures

Primary Outcomes (1)

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

    Day 1

Secondary Outcomes (1)

  • number of patients with staphylococcus aureus carriage in the vestibulum nasi

    Day 1

Study Arms (1)

Patient undergoing otorhinolaryngologic surgery

EXPERIMENTAL

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

Interventions

Staphylococcus aureus carriageOTHER

Vestibulum nasi and posterior nasal cavity sampling with swabs and posterior nasal cavity sampling by endoscopic procedure during otorhinolaryngologic surgery

Patient undergoing otorhinolaryngologic surgery

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Paul Verhoeven

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 3, 2015

Study Start

February 4, 2016

Primary Completion

September 4, 2017

Study Completion

September 5, 2017

Last Updated

January 30, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)