Nosocomial InfectionsNCT02756351
A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
A study testing CytaCoat Nasal Prong and Inspiration Healthcare Inspire nCPAP Nasal Prong in people with Nosocomial Infections and Pneumonia, Ventilator-Associated, run by CytaCoat AB at 1 site in Sweden.
Trial summary
The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nosocomial Infections, Pneumonia, Ventilator-Associated
- What is being tested?
- CytaCoat Nasal Prong and Inspiration Healthcare Inspire nCPAP Nasal Prong
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF).
- Subject is between 18 and 65 years of age.
- Subjects that have intact, wound free and scar free skin at the Nasal Prong target site.
- Subject that have intact, irritation-free nasal mucus membrane.
Who cannot join
- Pregnant or nursing women.
- Subjects who are active smokers or using snuff.
- Subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea.
- Subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study.
- Subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study.
- Subjects using and/or subjects that have used oral or topical anti-inflammatory drugs within 1 week prior to entering the study.
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- Subjects participating in any other clinical study.
- Subjects diagnosed with any type of skin infection (bacterial, viral or fungal) or inflammatory skin disease including psoriasis, eczema or severe acne
- Subjects diagnosed with any type disease affecting mucus membranes.
- Subjects suffering from any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment.
- Subjects who have a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the Nasal Prong target site
- Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Neonatal, Karolinska University Hospital
Stockholm, Stockholm County, 171 76
About this study
Official title: A Double-blinded Randomized Clinical Pilot Trial of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units.
- Being tested
- CytaCoat Nasal Prong, Inspiration Healthcare Inspire nCPAP Nasal Prong
- Medical subject headings
- Cross Infection, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytaCoat Nasal ProngDevice
Inspiration Healthcare Inspire nCPAP Nasal ProngDevice
| Study group | Role | What they receive |
|---|---|---|
| CytaCoat Nasal Prong | Experimental | The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. Receives: Device: CytaCoat Nasal Prong |
| Reference Nasal Prong | Active comparator | Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device. Receives: Device: Inspiration Healthcare Inspire nCPAP Nasal Prong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device.
Measured: 18 hours
Secondary outcomes (1)
Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study.
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nosocomial InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytaCoat AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baldvin Jonsson, Principal investigator, Neonatal, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756351
- Sponsor's protocol ID
- CCNP-01
- Status last verified
- Dec 2016
- First submitted
- 26 Apr 2016
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Randomized Clinical Pilot Trial of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
- ClinicalTrials.gov ID
- NCT02756351
- Acronym / sponsor ID
- CCNP-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CytaCoat ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 1 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CytaCoat Nasal Prong | Experimental | Device: CytaCoat Nasal ProngThe CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. |
| Reference Nasal Prong | Active comparator | Device: Inspiration Healthcare Inspire nCPAP Nasal ProngInspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF).
- Subject is between 18 and 65 years of age.
- Subjects that have intact, wound free and scar free skin at the Nasal Prong target site.
- Subject that have intact, irritation-free nasal mucus membrane.
Key exclusion criteria (12 listed)
- Pregnant or nursing women.
- Subjects who are active smokers or using snuff.
- Subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea.
- Subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study.
- Subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study.
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 |
|---|---|---|
| CytaCoat Nasal Prong | Device | CytaCoat Nasal Prong |
| Inspiration Healthcare Inspire nCPAP Nasal Prong | Device | Reference Nasal Prong |
Primary outcome
Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device.
Time frame: 18 hours
1 secondary outcome
Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study.
Time frame: 18 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Baldvin Jonsson principal investigator
Neonatal, Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytaCoat Nasal Prong and Inspiration Healthcare Inspire nCPAP Nasal Prong in people with Nosocomial Infections and Pneumonia, Ventilator-Associated, run by CytaCoat AB at 1 site in Sweden.
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 4 inclusion and 12 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 1 Feb 2017. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 1 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device. (time frame: 18 hours). 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 1 Feb 2017.