NCT02924103

Brief Summary

A test of a newly designed device (Contamination free bacterial swab). This device can be used to introduce a standard bacterial swab into the nose without direct or indirect contact with the nasal vestibule.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 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

June 6, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

June 6, 2016

Last Update Submit

April 10, 2018

Conditions

Sinusitis

Keywords

acute rhinosinusitisstaphylococcus aureusnasal vestibulecontamination

Outcome Measures

Primary Outcomes (1)

  • Frequency of staphylococcus aureus positive cultures

    Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose

    1 year

Secondary Outcomes (1)

  • Frequency of other bacteria in cultures

    1 year

Study Arms (2)

Right side

ACTIVE COMPARATOR

All included participants serve as their own control. A bacterial swab (Eswab 481CE, Copan Diagnostics, Italy), will be introduced to both sides of the nose (to the middle meatus); on the RIGHT side by using the "Contamination free bacterial swab" introduction device. The "Contamination free bacterial swab" introduction device is a prototype developed for clinical testing.

Device: Contamination free bacterial swab

Left side

ACTIVE COMPARATOR

All included participants serve as their own control. A bacterial swab (Eswab 481CE, Copan Diagnostics, Italy) will be introduced to both sides of the nose (to the middle meatus); on the LEFT side using the present day clinical procedure (visually guided introduction).

Device: Contamination free bacterial swab

Interventions

Contamination free bacterial swabDEVICE

A comparison of the bacteriology in bacterial swabs (Eswab 481CE, Copan Diagnostics, Italy) from the middle meatus. On the RIGHT side using the "Contamination free bacterial swab" introduction device that facilitates the introduction of a bacterial swab into the nose without direct or indirect contact with the nasal vestibule.

Left sideRight side

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptoms of upper airway disease

You may not qualify if:

  • mental illness
  • Need for interpreter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ørelæge Steffen Ørntoft

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

SinusitisStaphylococcal Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Steffen Ørntoft, MD

    Steffen Ørntoft, Ear, Nose and Throat specialist clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Ph.D

Study Record Dates

First Submitted

June 6, 2016

First Posted

October 5, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

DK(1)