Colonization, AsymptomaticNCT05617729
A Clinical Simulation Study of a Test Material on the Anterior Nares
A study testing Saline applied via swab and Povidone-iodine based gel in people with Colonization, Asymptomatic, run by Center for Innovation and Research Organization at 1 site in United States.
Trial summary
The objective of this study is simulate the clinical use of a test material within a 24h window. Efficacy will be simulated as the capacity of the material to reduce or clear the anterior nares bacterial population from opportunistic pathogens (e.g. Staphylococcus Aureus, Escherichia Coli, etc). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonization, Asymptomatic
- What is being tested?
- Saline applied via swab and Povidone-iodine based gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 31 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or female between 18 to 55 years of age;
- Subject has normal nasal passage;
- Subject has not history of chronic nasal passage disease (chronic rhinitis, chronic sinusitis).
- Subject is willing to have materials applied and follow the protocol;
- Subject agrees to avoid exposure of the test sites to any chemical product and to refrain from touching the area of application.
- Subject agrees to refrain from getting the application site wet and scrubbing or washing the test area with soap or applying powders, lotions or personal care products to the area during the course of the study;
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- Subject agrees not to introduce any new cosmetic or toiletry products during the study;
- Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
- Subject is willing to participate in all study evaluations;
- Subject is in generally good health;
- Subject understands and is willing to sign an Informed Consent Form
Who cannot join
- Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
- Subject has a chronic nasal disease (e.g sinusitis, rhinitis);
- Subject has a bleeding disorder, immunologically compromised, recent illness/vaccination or currently febrile;
- Subject reports a history of allergies to antiseptics;
- Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
- Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Innovation and Research Organization
Philadelphia, Pennsylvania, 19107
About this study
The objective of this study is simulate the clinical use of a test material within a 24h window. Efficacy will be simulated as the capacity of the material to reduce or clear the anterior nares bacterial population from opportunistic pathogens (e.g. Staphylococcus Aureus, Escherichia Coli, etc).
- Conditions
- Colonization, Asymptomatic
- Being tested
- Saline applied via swab, Povidone-iodine based gel
- Medical subject headings
- Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline applied via swabOther
sterile saline applied via swab
Povidone-iodine based gelOther
gel applied via swab
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | this treatment consists of sterile saline that is applied to the nares using a swab Receives: Other: Saline applied via swab |
| Povidone-iodine based gel | Active comparator | this treatment consists of a Povidone-Iodine based gel that is applied to the nares using a swab Receives: Other: Povidone-iodine based gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colony Forming Units
Measured: up to 24 hours following application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start7 Mar 2022
- Primary completion18 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonization, AsymptomaticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Innovation and Research Organization
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617729
- Sponsor's protocol ID
- Povinez001
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandez-Rodriguez D, Cho J, Chisari E, Citardi MJ, Parvizi J. Nasal microbiome and the effect of nasal decolonization with a novel povidone-iodine antiseptic solution: a prospective and randomized clinical trial. Sci Rep. 2024 Jul 20;14(1):16739. doi: 10.1038/s41598-023-46792-8.
PubMed 39033201
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Simulation Study of a Test Material on the Anterior Nares
- ClinicalTrials.gov ID
- NCT05617729
- Acronym / sponsor ID
- Povinez001
- Conditions
- Colonization, Asymptomatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Center for Innovation and Research OrganizationResearch network
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 15 Nov 2022 (actual)
- 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.
The objective of this study is simulate the clinical use of a test material within a 24h window. Efficacy will be simulated as the capacity of the material to reduce or clear the anterior nares bacterial population from opportunistic pathogens (e.g. Staphylococcus Aureus, Escherichia Coli, etc).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Other: Saline applied via swabthis treatment consists of sterile saline that is applied to the nares using a swab |
| Povidone-iodine based gel | Active comparator | Other: Povidone-iodine based gelthis treatment consists of a Povidone-Iodine based gel that is applied to the nares using a swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is male or female between 18 to 55 years of age;
- Subject has normal nasal passage;
- Subject has not history of chronic nasal passage disease (chronic rhinitis, chronic sinusitis).
- Subject is willing to have materials applied and follow the protocol;
- Subject agrees to avoid exposure of the test sites to any chemical product and to refrain from touching the area of application.
Key exclusion criteria (6 listed)
- Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
- Subject has a chronic nasal disease (e.g sinusitis, rhinitis);
- Subject has a bleeding disorder, immunologically compromised, recent illness/vaccination or currently febrile;
- Subject reports a history of allergies to antiseptics;
- Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with 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 |
|---|---|---|
| Saline applied via swabsterile saline applied via swab | Other | Saline |
| Povidone-iodine based gelgel applied via swab | Other | Povidone-iodine based gel |
Primary outcome
Colony Forming Units
Time frame: up to 24 hours following application
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 15 Nov 2022.
- Derived from this study: PubMed 39033201Fernandez-Rodriguez D, Cho J, Chisari E, Citardi MJ, Parvizi J. Nasal microbiome and the effect of nasal decolonization with a novel povidone-iodine antiseptic solution: a prospective and randomized clinical trial. Sci Rep. 2024 Jul 20;14(1):16739. doi: 10.1038/s41598-023-46792-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline applied via swab and Povidone-iodine based gel in people with Colonization, Asymptomatic, run by Center for Innovation and Research Organization at 1 site in United States.
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 11 inclusion and 6 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 15 Nov 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Colony Forming Units (time frame: up to 24 hours following application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05617729, which also lists 1 linked publication.
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 15 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.