NCT05617729

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

11 days

First QC Date

November 8, 2022

Last Update Submit

November 8, 2022

Conditions

Colonization, Asymptomatic

Outcome Measures

Primary Outcomes (1)

  • Colony Forming Units

    up to 24 hours following application

Study Arms (2)

Saline

PLACEBO COMPARATOR

this treatment consists of sterile saline that is applied to the nares using a swab

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

Other: Povidone-iodine based gel

Interventions

Saline applied via swabOTHER

sterile saline applied via swab

Saline
Povidone-iodine based gelOTHER

gel applied via swab

Povidone-iodine based gel

Eligibility Criteria

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

You may qualify if:

  • 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;
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Innovation and Research Organization

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 39033201DERIVED

MeSH Terms

Conditions

Asymptomatic Infections

Condition Hierarchy (Ancestors)

InfectionsAsymptomatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 15, 2022

Study Start

March 7, 2022

Primary Completion

March 18, 2022

Study Completion

March 31, 2022

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations

US(1)