Infection
Conditions
Keywords
Skin colonization, Catheter colonization, Catheter site infection
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.
Interventions
DRUGomiganan 1% gel
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.
DRUGchlorhexidine 2% solution
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.
Sponsors
Cadence Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours | Prior to first application (0 hours) to 72 hours post application | 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 | Prior to first application (0 hours) to 7 days post application. | 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) | Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days. | Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Subjects required screening skin samples ( from an average of 2 samples) containing at least 2.5log10 colony forming units per cm2 (CFU/cm2)
Participants by arm
| Arm | Count |
|---|---|
| Omiganan 1% Gel (Part 2) 25 subjects were treated with omiganan 1% gel at skin and intravenous (IV) sites in Part 2. | 25 |
| Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1) 25 subjects were treated with chlorhexidine 2% and omiganan 1% in Part 1. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Part 1 | Did not meet eligibility criteria | 1 |
Baseline characteristics
| Characteristic | Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1) | Omiganan 1% Gel (Part 2) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2.0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 48.0 Participants |
| Age Continuous | 36.6 years STANDARD_DEVIATION 15.13 | 38.6 years STANDARD_DEVIATION 15.13 | 38.6 years STANDARD_DEVIATION 15.13 |
| Region of Enrollment United States | 25 participants | 25 participants | 50.0 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25.0 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 7 / 25 | 8 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: Prior to first application (0 hours) to 72 hours post application
Population: ITT set consists of all subjects who received at least one study treatment and had data available at 72 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omiganan 1% Gel (Part 2) | Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours | -1.91 log 10 CFU/cm sq | Standard Deviation 1.563 |
| Chlorhexidine 2%(Part 1) | Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours | -1.87 log 10 CFU/cm sq | Standard Deviation 1.656 |
Comparison: Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.p-value: <0.00195% CI: [-2.55, -1.26]t-test, 2 sided
Comparison: Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.p-value: <0.00195% CI: [-2.57, -1.17]t-test, 2 sided
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.
Time frame: Prior to first application (0 hours) to 7 days post application.
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omiganan 1% Gel (Part 2) | Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days | -1.44 log 10 CFU/sq. cm | Standard Deviation 1.511 |
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.
Time frame: Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days.
Population: intravenous (IV) catheters were removed for culture from 5 subjects at 72 hours, 10 subjects at 5 days, and 10 subjects at 7 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omiganan 1% Gel (Part 2) | Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) | 0 participants |
| Chlorhexidine 2%(Part 1) | Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) | 1 participants |