Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine if omiganan 1% gel (the investigational medication in this research study) is effective and safe when compared to chlorhexidine 2% (an FDA approved medication) for killing bacteria (germs) that live on the surface of the skin. Both of the study medications are applied topically (on the surface of the skin).

Detailed Description
-----------------
The study is comprised of 2 parts with approximately 20 subjects participating in each part. Subjects eligible for Part 1 will have omiganan 1 % gel applied to 6 sites across the chest and/or abdomen and chlorhexidine 2% solution will be applied to 6 matching sites on the contralateral side. Subjects eligible for Part 2 will each have omiganan 1% gel applied to 6 sites across the upper chest or abdomen.In addition,subjects in Part 2 will have 2 peripheral catheters inserted, one in each arm.One catheter insertion site will be treated with omiganan 1% gel (following treatment with isopropyl alcohol) and the other site will be treated with chlorhexidine 2%/isopropyl alcohol.

Official Title
-----------------
A Single- Center, Open-Label, Study of the Persistence of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: omiganan 1% gel
* Drug: chlorhexidine 2% solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects18-70 years of age No evidence of dermatosis, dermatitis, inflammation, scarring, or acute injuries to the drug application sites on the chest or abdomen Subjects must have screening samples from the skin on the right and left side of the chest or abdomen containing at least 2.5 log10 colony forming units per square centimeter (CFU/cm2 )organisms (from the average of 2 samples obtained during screening) Willing to provide written informed consent. Exclusion Criteria: Allergies or sensitivities to alcohol, adhesive tape, bandages, latex, chlorhexidine gluconate, or any of the ingredients of omiganan 1% gel Prior treatment with any systemic antibiotic, or any other product known to affect the normal microbial flora of the skin within 7 days of the screening examination Requirement for topical antibiotic use on or within 10 cm of any study test site Subjects who have been treated with any investigational drug (other than omiganan) within the previous 30 days, or who are participating in an investigational drug study at any time during the course of this study Subjects who have been previously treated with omiganan and experienced a possibly related adverse event during the study Note: a wash out period of one week is required prior to participation in Part 2 of the study A medical condition that the Investigator believes may interfere with the safety of the subject or the intent and conduct of the study Note: this includes conditions such as: severe eczema, psoriasis and/or dermal infections, old scars, insulin dependent diabetes mellitus, severe immunocompromising conditions, HIV infection, or use of medications that would interfere with assessment of study endpoints A current or recent history of illicit drug or alcohol abuse Subjects not willing or able to fulfill protocol requirements Pregnancy. Women of childbearing potential who have a positive or equivocal result on a urine and/or blood pregnancy test before study enrollment will not be included

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omiganan 1% gel<br>Omiganan has a rapid bactericidal and fungicidal effect which is under development for the prevention of infections arising from short-term central venous catheters, as well as for the prevention of surgical wound infections in contaminated wounds. | Drug: omiganan 1% gel<br>* Omiganan 1% gel will be applied to 6 sites on the chest and/or abdomen.Swab cultures will be obtained at specified timepoints over a period of 3 days (Part1) or 7 days (Part 2). In addition, subjects in Part 2 will have omiganan 1% gel applied to one intravenous (IV) catheter site.<br>|
| Active Comparator: chlorhexidine 2%<br> | Drug: chlorhexidine 2% solution<br>* Part 1- chlorhexidine 2% solution will be applied to 6 sites on the chest and/or abdomen. All application sites will be covered with semi-transparent dressings.Swab cultures will be obtained at specific timepoints over a period of 3 days. Part 2: Subjects in Part 2 will have chlorhexidine 2% solution applied to one intravenous (IV) catheter site only.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours | Change in the mean number of skin bacterial counts (CFU/cm2) which was calculated by subtracting log10 CFU/cm2 at 72 hours (single sample per subject per timepoint) from the log10 CFU/cm2 at 0 hours (baseline) in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint. | Prior to first application (0 hours) to 72 hours post application | 
| Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days | Change in the mean number of skin bacterial counts (log 10 CFU/cm2)which was calculated by subtracting log10 CFU/cm2 at 7 days (one sample per site per subject per timepoint) from log10CFU/cm2 at 0 hours in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint. | Prior to first application (0 hours) to 7 days post application. | 
| Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) | Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion. | Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin colonization, Catheter colonization, Catheter site infection