Back to results

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

Primary Purpose

Infection

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

omiganan 1% gel

chlorhexidine 2% solution

About this trial

This is an interventional prevention trial for Infection focused on measuring Skin colonization, Catheter colonization, Catheter site infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

BioSciences Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

omiganan 1% gel

chlorhexidine 2%

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00608959

First Posted

January 23, 2008

Last Updated

January 22, 2010

Sponsor

Cadence Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00608959

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cadence Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection

Keywords

Skin colonization, Catheter colonization, Catheter site infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

omiganan 1% gel

Arm Type

Experimental

Arm Description

Arm Title

chlorhexidine 2%

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

omiganan 1% gel

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

chlorhexidine 2% solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours

Description

Time Frame

Prior to first application (0 hours) to 72 hours post application

Title

Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days

Description

Time Frame

Prior to first application (0 hours) to 7 days post application.

Title

Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs)

Description

Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion.

Time Frame

Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine J Hardalo, MD

Organizational Affiliation

Cadence Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

BioSciences Lab

City

Bozeman

State/Province

Montana

ZIP/Postal Code

59715

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs