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This single site study is a randomized, controlled, partially-blinded design enrolling a minimum of 516 healthy volunteers, where each subject will receive two of the planned study products on the product application sites of the abdomen and/or groin.
To demonstrate the antimicrobial activity of the Investigational Product (IP) by comparing counts of resident skin microbes, obtained after IP application to intact skin of the abdomen and groin, to counts obtained prior to application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental | Skin will be prepared with investigational product |
|
| Reference Standard | Other | Skin will be prepared with reference standard |
|
| Active Control | Active Comparator | Skin will be prepared with active comparator |
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| Negative Control | Other | Skin will be prepared with negative control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Product | Combination Product | 2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard 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. | 30 seconds and 6 hours post-product application |
| Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 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. | Baseline and 10 minutes post-product application |
| Responder Rate at 6 Hours Post-Product Application on the Abdomen. | Number of participants with bacterial reduction greater than or equal to baseline (0). | 6 hours post-product application |
| Responder Rate at 6 Hours Post-Product Application on the Groin. | Number of participants with bacterial reduction greater than or equal to baseline (0). | 6 hours post-product application |
| Measure | Description | Time Frame |
|---|---|---|
| Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 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. | Baseline and 30 seconds post-product application |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Evic Product Testing Romania S.R.L. | Bucharest | 040256 | Romania |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Study Participants that were treated |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Participants Who Completed Evaluations |
| 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, Continuous | Mean |
| 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 | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard 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. | 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. | Posted | Mean | 95% Confidence Interval | Log10 CFU/cm^2 | 30 seconds and 6 hours post-product application |
|
6 hours
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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 | Investigational Product | Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Zook, PhD | Becton Dickinson | 224-358-5019 | erin.zook@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2019 | Jul 9, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 2, 2019 | Jul 9, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012015 | Reference Standards |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
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Healthy adult volunteers that meet inclusion/exclusion criteria will be randomized to receive 2 of the 4 products on bilateral site on the abdomen and/or groin.
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Study products cannot be blinded to staff member(s) performing product applications, sample collections.
Staff member(s) performing bacterial enumeration will be blinded from the identification of all study product assignments.
| Reference Standard | Other | 60% (v/v) 1-propanol skin preparation |
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| Active Comparator | Combination Product | ChloraPrep® SEPP® skin preparation |
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| Negative Control | Other | 0.9% Normal Saline skin preparation |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol
| OG001 | Reference Standard | 1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick |
|
|
| Primary | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 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. | 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. | Posted | Mean | Standard Deviation | Log10 CFU/cm^2 | Baseline and 10 minutes post-product application |
|
|
|
|
| Primary | Responder Rate at 6 Hours Post-Product Application on the Abdomen. | Number of participants with bacterial reduction greater than or equal to baseline (0). | 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. | Posted | Count of Participants | Participants | 6 hours post-product application |
|
|
|
| Primary | Responder Rate at 6 Hours Post-Product Application on the Groin. | Number of participants with bacterial reduction greater than or equal to baseline (0). | 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. | Posted | Count of Participants | Participants | 6 hours post-product application |
|
|
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| Secondary | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 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. | 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. | Posted | Mean | Standard Deviation | Log10 CFU/cm^2 | Baseline and 30 seconds post-product application |
|
|
|
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| 0 |
| 609 |
| 0 |
| 609 |
| 0 |
| 609 |
| EG001 | Reference Standard | 1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick | 0 | 419 | 0 | 419 | 0 | 419 |
| EG002 | Active Control | ChloraPrep® SEPP® clear applicator- 2% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol | 0 | 609 | 0 | 609 | 0 | 609 |
| EG003 | Negative Control | 1.75mL 0.9% Normal saline applied with a single Swabstick | 0 | 605 | 0 | 605 | 0 | 605 |
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| Abdomen 10 Minutes |
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| Groin Baseline |
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| Groin 10 Minutes |
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A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).
| Groin at 10 minutes post-product application. Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate. | Mean Difference (Final Values) | -0.24 | 2-Sided | 95 | -0.43 | -0.05 | Non-Inferiority | A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10). |
| Abdomen at 10 minutes post-product application. Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate. | Mean Difference (Final Values) | 1.82 | 2-Sided | 95 | 1.66 | 1.97 | Superiority |
| Groin at 10 minutes post-product application. Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate. | Mean Difference (Final Values) | 2.38 | 2-Sided | 95 | 2.19 | 2.56 | Superiority |
| Abdomen 30 seconds |
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| Groin Baseline |
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| Groin 30 seconds |
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A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).
| Abdomen at 30 seconds post-product application. Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate. | Mean Difference (Final Values) | 1.99 | 2-Sided | 95 | 1.84 | 2.15 | Superiority |