Trial Outcomes & Findings for Evaluation of the Antimicrobial Effectiveness of CHG/IPA (NCT NCT04035161)
NCT ID: NCT04035161
Last Updated: 2021-08-17
Results Overview
Bacterial log10/cm\^2 reductions for abdominal and groin sites post-product application (30 seconds and 6 hours) using the Investigational Product or Reference Standard.
COMPLETED
1935 participants
30 seconds and 6 hours post-product application
2021-08-17
Participant Flow
Participants were only treated if screening day baseline bacterial counts met the inclusion criteria. Participants were treated with 2 out of 4 study products (Investigational Product, Reference Standard, Active control and Negative Control) 1 on the left side of the body (both groin and abdomen), 1 on the right side of the body (both groin and abdomen).
Participant milestones
| Measure |
All Study Participants
Study Participants that were treated
|
|---|---|
|
Overall Study
STARTED
|
1121
|
|
Overall Study
Treated With Investigational Product
|
609
|
|
Overall Study
Treated With Reference Standard
|
419
|
|
Overall Study
Treated With Active Control
|
609
|
|
Overall Study
Treated With Negative Control
|
605
|
|
Overall Study
COMPLETED
|
1121
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Antimicrobial Effectiveness of CHG/IPA
Baseline characteristics by cohort
| Measure |
All Study Participants
n=1121 Participants
All Participants Who Completed Evaluations
|
|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
205 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
916 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
1121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 seconds and 6 hours post-product applicationPopulation: This outcome includes test requirements outlined by Health Canada (HC) for an investigational product to demonstrate immediate and persistent antimicrobial activity against a reference standard, 60% v/v 1-Propanol. This outcome does not include negative and active control comparators. Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 30 seconds and 6 hours post-product application.
Bacterial log10/cm\^2 reductions for abdominal and groin sites post-product application (30 seconds and 6 hours) using the Investigational Product or Reference Standard.
Outcome measures
| Measure |
Investigational Product
n=609 Participants
Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol
|
Reference Standard
n=419 Participants
1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick
|
Negative Control
1.75mL 0.9% Normal saline applied with a single Swabstick
|
|---|---|---|---|
|
Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application
Groin 6 hours
|
3.89 Log10 CFU/cm^2
Interval 3.73 to 4.04
|
4.08 Log10 CFU/cm^2
Interval 3.9 to 4.27
|
—
|
|
Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application
Abdomen 30 Seconds
|
2.53 Log10 CFU/cm^2
Interval 2.39 to 2.67
|
2.70 Log10 CFU/cm^2
Interval 2.53 to 2.87
|
—
|
|
Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application
Abdomen 6 hours
|
2.68 Log10 CFU/cm^2
Interval 2.54 to 2.82
|
2.73 Log10 CFU/cm^2
Interval 2.57 to 2.89
|
—
|
|
Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application
Groin 30 Seconds
|
3.69 Log10 CFU/cm^2
Interval 3.53 to 3.84
|
4.07 Log10 CFU/cm^2
Interval 3.89 to 4.25
|
—
|
PRIMARY outcome
Timeframe: Baseline and 10 minutes post-product applicationPopulation: This outcome includes FDA test requirements for an investigational product (IP) to demonstrate superior antimicrobial activity to a negative control and non-inferiority to an active control at the immediate time point of 10 minutes on the abdomen and groin. This outcome does not require a reference standard. Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 10 minutes post-product application.
Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin.
Outcome measures
| Measure |
Investigational Product
n=609 Participants
Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol
|
Reference Standard
n=609 Participants
1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick
|
Negative Control
n=605 Participants
1.75mL 0.9% Normal saline applied with a single Swabstick
|
|---|---|---|---|
|
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.
Abdomen Baseline
|
3.93 Log10 CFU/cm^2
Standard Deviation .61
|
3.88 Log10 CFU/cm^2
Standard Deviation .58
|
4.00 Log10 CFU/cm^2
Standard Deviation .62
|
|
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.
Groin Baseline
|
6.14 Log10 CFU/cm^2
Standard Deviation .47
|
6.16 Log10 CFU/cm^2
Standard Deviation .46
|
6.17 Log10 CFU/cm^2
Standard Deviation .48
|
|
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.
Groin 10 Minutes
|
2.46 Log10 CFU/cm^2
Standard Deviation 1.36
|
2.70 Log10 CFU/cm^2
Standard Deviation 1.32
|
4.84 Log10 CFU/cm^2
Standard Deviation .70
|
|
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.
Abdomen 10 Minutes
|
1.34 Log10 CFU/cm^2
Standard Deviation 1.13
|
1.31 Log10 CFU/cm^2
Standard Deviation 1.04
|
3.19 Log10 CFU/cm^2
Standard Deviation .80
|
PRIMARY outcome
Timeframe: 6 hours post-product applicationPopulation: This outcome includes FDA test requirements to demonstrate persistence of the investigational product (IP) at 6 hours post-product application on the abdomen. This outcome does not require a reference standard. Analysis only includes participants with required treatment day baseline bacterial counts on the abdomen at baseline and non-missing data at 6 hours post-product application.
Number of participants with bacterial reduction greater than or equal to baseline (0).
Outcome measures
| Measure |
Investigational Product
n=291 Participants
Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol
|
Reference Standard
n=307 Participants
1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick
|
Negative Control
n=303 Participants
1.75mL 0.9% Normal saline applied with a single Swabstick
|
|---|---|---|---|
|
Responder Rate at 6 Hours Post-Product Application on the Abdomen.
|
286 Participants
|
305 Participants
|
265 Participants
|
PRIMARY outcome
Timeframe: 6 hours post-product applicationPopulation: This outcome includes FDA test requirements to demonstrate persistence of the investigational product (IP) at 6 hours post-product application on the groin. This outcome does not require a reference standard. Analysis only includes participants with required treatment day baseline bacterial counts on the groin at baseline and non-missing data at 6 hours post-product application.
Number of participants with bacterial reduction greater than or equal to baseline (0).
Outcome measures
| Measure |
Investigational Product
n=295 Participants
Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol
|
Reference Standard
n=293 Participants
1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick
|
Negative Control
n=295 Participants
1.75mL 0.9% Normal saline applied with a single Swabstick
|
|---|---|---|---|
|
Responder Rate at 6 Hours Post-Product Application on the Groin.
|
295 Participants
|
293 Participants
|
291 Participants
|
SECONDARY outcome
Timeframe: Baseline and 30 seconds post-product applicationPopulation: This outcome includes FDA test requirements for an investigational product (IP) to demonstrate superior antimicrobial activity to a negative control and non-inferiority to an active control at the immediate time point of 30 seconds on the abdomen and groin. This outcome does not require a reference standard. Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 30 seconds post-product application.
Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin.
Outcome measures
| Measure |
Investigational Product
n=609 Participants
Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol
|
Reference Standard
n=609 Participants
1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick
|
Negative Control
n=605 Participants
1.75mL 0.9% Normal saline applied with a single Swabstick
|
|---|---|---|---|
|
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application.
Groin 30 seconds
|
2.46 Log10 CFU/cm^2
Standard Deviation 1.36
|
2.80 Log10 CFU/cm^2
Standard Deviation 1.34
|
5.20 Log10 CFU/cm^2
Standard Deviation .62
|
|
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application.
Abdomen Baseline
|
3.93 Log10 CFU/cm^2
Standard Deviation .61
|
3.88 Log10 CFU/cm^2
Standard Deviation .58
|
4.00 Log10 CFU/cm^2
Standard Deviation .62
|
|
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application.
Abdomen 30 seconds
|
1.40 Log10 CFU/cm^2
Standard Deviation 1.19
|
1.30 Log10 CFU/cm^2
Standard Deviation 1.06
|
3.43 Log10 CFU/cm^2
Standard Deviation .72
|
|
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application.
Groin Baseline
|
6.14 Log10 CFU/cm^2
Standard Deviation .47
|
6.16 Log10 CFU/cm^2
Standard Deviation .46
|
6.17 Log10 CFU/cm^2
Standard Deviation .48
|
Adverse Events
Investigational Product
Reference Standard
Active Control
Negative Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place