Trial Outcomes & Findings for Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects (NCT NCT00608959)
NCT ID: NCT00608959
Last Updated: 2010-01-26
Results Overview
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.
COMPLETED
PHASE3
30 participants
Prior to first application (0 hours) to 72 hours post application
2010-01-26
Participant Flow
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.
Subjects required screening skin samples ( from an average of 2 samples) containing at least 2.5log10 colony forming units per cm2 (CFU/cm2)
Participant milestones
| Measure |
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.
|
|---|---|
|
Part 1
STARTED
|
25
|
|
Part 1
COMPLETED
|
24
|
|
Part 1
NOT COMPLETED
|
1
|
|
Part 2
STARTED
|
25
|
|
Part 2
COMPLETED
|
25
|
|
Part 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Part 1
Did not meet eligibility criteria
|
1
|
Baseline Characteristics
Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Omiganan 1% Gel (Part 2)
n=25 Participants
25 subjects were treated with omiganan 1% gel at skin and intravenous (IV) sites in Part 2.
|
Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1)
n=25 Participants
25 subjects were treated with chlorhexidine 2% and omiganan 1% in Part 1.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2.0 Participants
n=5 Participants
|
|
Age Continuous
|
38.6 years
STANDARD_DEVIATION 15.13 • n=5 Participants
|
36.6 years
STANDARD_DEVIATION 15.13 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 15.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25.0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50.0 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48.0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prior to first application (0 hours) to 72 hours post applicationPopulation: ITT set consists of all subjects who received at least one study treatment and had data available at 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.
Outcome measures
| Measure |
Omiganan 1% Gel (Part 2)
n=25 Participants
Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 3 days.
|
Chlorhexidine 2%(Part 1)
n=24 Participants
Chlorhexidine 2% solution was applied to 6 sites on the chest and/or abdomen. Swab cultures were obtained at specific timepoints over 3 days.
|
|---|---|---|
|
Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours
|
-1.91 log 10 CFU/cm sq
Standard Deviation 1.563
|
-1.87 log 10 CFU/cm sq
Standard Deviation 1.656
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Omiganan 1% Gel (Part 2)
n=25 Participants
Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 3 days.
|
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.
|
|---|---|---|
|
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 outcome
Timeframe: 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.
Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion.
Outcome measures
| Measure |
Omiganan 1% Gel (Part 2)
n=25 Participants
Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 3 days.
|
Chlorhexidine 2%(Part 1)
n=24 Participants
Chlorhexidine 2% solution was applied to 6 sites on the chest and/or abdomen. Swab cultures were obtained at specific timepoints over 3 days.
|
|---|---|---|
|
Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs)
|
0 participants
|
1 participants
|
Adverse Events
Omiganan 1% Gel (Part 1)
Chlorhexidine
Omiganan 1% (Part 2)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omiganan 1% Gel (Part 1)
n=25 participants at risk
In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen.
|
Chlorhexidine
n=25 participants at risk
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.
|
Omiganan 1% (Part 2)
n=25 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/25 • 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.
|
8.0%
2/25 • Number of events 2 • 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.
|
8.0%
2/25 • Number of events 2 • 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.
|
|
General disorders
Catheter Site Pain
|
—
0/0 • 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.
|
28.0%
7/25 • Number of events 7 • 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.
|
28.0%
7/25 • Number of events 7 • 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.
|
Additional Information
Catherine J Hardalo, MD Vice President, Anti-Infectives Clinical Development
Cadence Pharmaceuticals, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60