SinusitisNCT02924103
Contamination Free Bacterial Swap
A study testing Contamination free bacterial swab in people with Sinusitis, run by Kåre Håkansson at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- Contamination free bacterial swab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptoms of upper airway disease
Who cannot join
- mental illness
- Need for interpreter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)
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.
Read the detailed description
Aim:
The investigators want to improved the current method for bacterial culture test in patients with possible sinusitis by reducing the risk of contamination from the nasal vestibule. The investigators will examine whether significantly fewer Staphylococcus Aureus are detected in the middle meatus when applying a new device for bacterial swab introduction. This device is designed to prevent bacterial pollution from the nasal vestibule.
More precisely, the investigators hope to reduce the frequency of Staphylococcus aureus in nasal swabs from 10-15 % to 0-5 %.
The overall objective is to avoid over-treatment with broad-spectrum antibiotics in patients with sino-nasal disease.
Design:
A comparative study in which patients serve as their own control. A bacterial swab will be introduced to both sides of the nose; on the right side using the new device, on the left side using the present day technique (visual guidance). 70 participants will be included.
Statistics:
A chi-square test will be used for comparison of frequencies.
- Conditions
- Sinusitis
- Being tested
- Contamination free bacterial swab
- Keywords
- acute rhinosinusitis, staphylococcus aureus, nasal vestibule, contamination
- Medical subject headings
- Sinusitis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Contamination free bacterial swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of staphylococcus aureus positive cultures
Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose
Measured: 1 year
Secondary outcomes (1)
Frequency of other bacteria in cultures
Comparison of the frequency of other positive cultures from the two sides of the nose
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kåre Håkansson
- Sponsor type
- University, hospital or other
- Collaborators
- Region Capital Denmark
- Responsible party
- Sponsor-investigator, Kåre Håkansson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Steffen Ørntoft, MD, Principal investigator, Steffen Ørntoft, Ear, Nose and Throat specialist clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924103
- Sponsor's protocol ID
- CIV-16-04-015264
- Status last verified
- Apr 2018
- First submitted
- 6 Jun 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)
- ClinicalTrials.gov ID
- NCT02924103
- Acronym / sponsor ID
- CIV-16-04-015264
- Conditions
- Sinusitis
- Keywords
- acute rhinosinusitis, staphylococcus aureus, nasal vestibule, contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kåre HåkanssonUniversity, hospital or other
- Collaborators
- Region Capital Denmark
- Study start
- Dec 2016
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim:
The investigators want to improved the current method for bacterial culture test in patients with possible sinusitis by reducing the risk of contamination from the nasal vestibule. The investigators will examine whether significantly fewer Staphylococcus Aureus are detected in the middle meatus when applying a new device for bacterial swab introduction. This device is designed to prevent bacterial pollution from the nasal vestibule.
More precisely, the investigators hope to reduce the frequency of Staphylococcus aureus in nasal swabs from 10-15 % to 0-5 %.
The overall objective is to avoid over-treatment with broad-spectrum antibiotics in patients with sino-nasal disease.
Design:
A comparative study in which patients serve as their own control. A bacterial swab will be introduced to both sides of the nose; on the right side using the new device, on the left side using the present day technique (visual guidance). 70 participants will be included.
Statistics:
A chi-square test will be used for comparison of frequencies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right side | Active comparator | Device: Contamination free bacterial swabAll 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. |
| Left side | Active comparator | Device: Contamination free bacterial swabAll 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptoms of upper airway disease
Key exclusion criteria (2 listed)
- mental illness
- Need for interpreter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contamination free bacterial swabA 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. | Device | Left side, Right side |
Primary outcome
Frequency of staphylococcus aureus positive cultures
Time frame: 1 year
Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose
1 secondary outcome
Frequency of other bacteria in cultures
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Sinusitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Ørntoft, MD principal investigator
Steffen Ørntoft, Ear, Nose and Throat specialist clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contamination free bacterial swab in people with Sinusitis, run by Kåre Håkansson at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of staphylococcus aureus positive cultures (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.