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

NCT00608959 | Completed Phase 3 Results

• 1 other identifier: CPI-226-301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Infection

Keywords

Skin colonization; Catheter colonization; Catheter site infection

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

omiganan 1% gel

EXPERIMENTAL

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

chlorhexidine 2%

ACTIVE COMPARATOR

Drug: chlorhexidine 2% solution

Interventions

omiganan 1% gel DRUG

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.

omiganan 1% gel

chlorhexidine 2% solution DRUG

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.

chlorhexidine 2%

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cadence Pharmaceuticals: lead

Study Sites (1)

BioSciences Lab

Bozeman, Montana, 59715, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Omiganan; Gels; Chlorhexidine; Solutions

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

FDA reviewer noted that there were multiple endpoints that required multiplicity adjustments to control for the overall type I error rate.Based on feedback the 72 hour endpoint was selected for Part 2 as the primary efficacy endpoint.

Results Point of Contact

• Title: Catherine J Hardalo, MD Vice President, Anti-Infectives Clinical Development
• Organization: Cadence Pharmaceuticals, Inc

chardalo@cadencepharm.com

858 4361439

Study Officials

• Catherine J Hardalo, MD

  Cadence Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 26, 2010
• Results First Posted: January 25, 2010

Record last verified: 2010-01

Locations

US (1)