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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| chlorhexidine 2% | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine J Hardalo, MD | Cadence Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSciences Lab | Bozeman | Montana | 59715 | United States |
Subjects required screening skin samples ( from an average of 2 samples) containing at least 2.5log10 colony forming units per cm2 (CFU/cm2)
Subjects were enrolled at a single center in the US, from 12 May 2008 - 03 June 2008. Subjects who participated in Part 1 were allowed to participate in Part 2 after a one week washout period.Subjects were not required to participate in both Parts 1 and 2 of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omiganan 1% Gel and Chlorhexidine | In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen and chlorhexidine applied to 6 matching sites on the contralateral side.Swab cultures were taken at specified timepoints over 72 hours. In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Swab cultures were taken at specified timepoints over 7 days.In addition subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
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| Part 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Omiganan 1% Gel (Part 2) | 25 subjects were treated with omiganan 1% gel at skin and intravenous (IV) sites in Part 2. |
| BG001 | Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT set consists of all subjects who received at least one study treatment and had data available at 72 hours. | Posted | Mean | Standard Deviation | log 10 CFU/cm sq | Prior to first application (0 hours) to 72 hours post application |
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Part 1:Baseline (prior to study medication),6 hrs, 24 hrs, 48 hrs, 72 hours after the application of study medication. Part 2: Baseline, 6 hrs, 24 hrs, 48 hrs, 72 hours, 5 days, 7 days after the application of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omiganan 1% Gel (Part 1) | In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Headache | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine J Hardalo, MD Vice President, Anti-Infectives Clinical Development | Cadence Pharmaceuticals, Inc | 858 4361439 | chardalo@cadencepharm.com |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000625752 | Omiganan |
| D005782 | Gels |
| D002710 | Chlorhexidine |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| 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. |
|
25 subjects were treated with chlorhexidine 2% and omiganan 1% in Part 1.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 |
| Chlorhexidine 2%(Part 1) |
Chlorhexidine 2% solution was applied to 6 sites on the chest and/or abdomen. Swab cultures were obtained at specific timepoints over 3 days. |
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| Primary | 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. | In Part 2 of the study 25 subjects had only omiganan applied to sites across the upper chest or abdomen.Swab cultures were obtained over a period of 7 days at protocol-specified times | Posted | Jun 2009 | Mean | Standard Deviation | log 10 CFU/sq. cm | Prior to first application (0 hours) to 7 days post application. |
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| Primary | 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. | intravenous (IV) catheters were removed for culture from 5 subjects at 72 hours, 10 subjects at 5 days, and 10 subjects at 7 days. | Posted | Jun 2009 | Number | participants | Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days. |
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Chlorhexidine | In Part 1 each subject had chlorhexidine 2% applied to 6 sites located across the chest and/or abdomen. In Part 2 subjects had chlorhexidine 2%/isopropyl alcohol applied to one intravenous (IV) catheter site. | 0 | 25 | 7 | 25 |
| EG002 | Omiganan 1% (Part 2) | In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Omiganan 1% gel was applied to one intravenous (IV) catheter site. | 0 | 25 | 8 | 25 |
| Catheter Site Pain | General disorders | MedDRA (10.1) | Non-systematic Assessment | IV catheters were inserted in subjects participating in Part 2 only. Part 1 subjects did not have IV catheters. |
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| D001645 |
| Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |