Microbial ColonizationNCT04035161

Evaluation of the Antimicrobial Effectiveness of CHG/IPA

A study testing Investigational Product, Reference Standard and Active Comparator in people with Microbial Colonization, run by Becton, Dickinson and Company at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Microbial Colonization
What is being tested?: Investigational Product, Reference Standard and Active Comparator
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,935 participants
Where: 1 siteRomania
Study dates: 17 Apr 2019to 24 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Read, understand, and provide signed informed consent.
Are healthy subjects in good general health
Are 18 years of age or older
If females of childbearing potential, are using an acceptable form of birth control for at least 28 days immediately preceding Day 1 and throughout the duration of the study. Acceptable methods are established, effective hormonal contraception (oral/implant/injectable/transdermal/intra-vaginal), intra-uterine device [IUD], diaphragm with spermicide, condom with spermicide, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who has had a vasectomy
In the case of females of childbearing potential, have a negative urine pregnancy test (UPT) on Product Application Day prior to any applications of the study products.
Are free of any systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
Have minimal Screening Day bacterial count.

Who cannot join

Have had exposure to topical or systemic antimicrobials or any other product known to affect the normal microbial flora of the skin, antibiotics or steroids (other than hormones for contraception or post-menopausal reasons) within the product restriction period and for the remainder of the study. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, and colognes.
Subjects who have a history of skin allergies.
Have known allergies or sensitivity to vinyl, latex (rubber), alcohols, metals, inks, common consumer/beauty products, tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine, or any other product components.
Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within the product restriction period and for the remainder of the study.
Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable product application areas) within the product restriction period and for the remainder of the study.
Have had exposure of the product application sites to strong detergents, acids, bases, bug repellant, fabric softener-treated clothing, UV treated clothing, other household chemicals in the applicable product application areas or other irritants during the product restriction period or during the study period.

Show all 17Show fewer

Have a history of skin cancer within 6 inches of applicable product application areas, or are currently being treated for skin cancer or have received treatment for any type of internal cancer within the 5 years prior to enrollment.
Subjects who have a history of asthma, diabetes, hepatitis B or C, an organ transplant, mitral valve prolapse with a heart murmur, congenital heart disease, lupus, Crohn's disease, medicated multiple sclerosis, internal prosthesis or any immunocompromised conditions (such as AIDS or HIV positive).
A currently active skin disease or inflammatory skin condition (for example contact dermatitis) anywhere on the body.
Any tattoos or scars (including stretch marks) on the product application sites or within 2 inches of the product application sites; skin blemishes or warts may be permissible with the specific approval of the Investigator or consulting physician.
Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches on or around the product application sites.
Subjects who have showered or bathed within at least 72 hours of the Product Application Day. Sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided.
Subjects who have an irritation score of 1 or greater (any redness, swelling, rash, or dryness present at any product application area) for any individual skin condition prior to the Product Application Day baseline sample collection.
Are females who are pregnant, plan to become pregnant during the study, or are breastfeeding a child.
Are unable to adhere to or understand the protocol.
Have used an investigational drug or participated in an investigational study within 30 days prior to signing the informed consent for this study or are currently participating in a clinical study.
Are employed by or are a family member of staff of BD or the study site conducting the study.

Trial locations and contacts

1 site in 1 country.

Romania1 site

Eurofins Evic Product Testing Romania S.R.L.
Bucharest, 040256

Other trials in Romania

About this study

Official title: Evaluation of the Antimicrobial Effectiveness of CHG/IPA in Healthy Volunteers

Read the detailed description

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.

Conditions: Microbial Colonization
Being tested: Investigational Product, Reference Standard, Active Comparator, Negative Control
Medical subject headings: Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational ProductCombination product
2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation
Reference StandardOther
60% (v/v) 1-propanol skin preparation
Active ComparatorCombination product
ChloraPrep® SEPP® skin preparation
Negative ControlOther
0.9% Normal Saline skin preparation

Study groups in NCT04035161
Study group	Role	What they receive
Investigational Product	Experimental	Skin will be prepared with investigational product Receives: Combination Product: Investigational Product
Reference Standard	Other	Skin will be prepared with reference standard Receives: Other: Reference Standard
Active Control	Active comparator	Skin will be prepared with active comparator Receives: Combination Product: Active Comparator
Negative Control	Other	Skin will be prepared with negative control Receives: Other: Negative Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 6 hours post-product application

Secondary outcomes (1)

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.
Measured: Baseline and 30 seconds post-product application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 201924 Dec 2019

First posted29 Jul 2019
Study start17 Apr 2019
Primary completion24 Dec 2019
Study completion24 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Microbial ColonizationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,935 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04035161
Sponsor's protocol ID: MPS-17IPVSS02
Status last verified: Jul 2021
First submitted: 10 Jul 2019
Last updated: 17 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Antimicrobial Effectiveness of CHG/IPA in Healthy Volunteers
ClinicalTrials.gov ID: NCT04035161
Acronym / sponsor ID: MPS-17IPVSS02
Conditions: Microbial Colonization
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,935 participants (actual)
Lead sponsor: Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
Study start: 17 Apr 2019 (actual)
Primary completion: 24 Dec 2019 (actual)
Study completion: 24 Dec 2019 (actual)
First posted: 29 Jul 2019 (actual)
Results: Posted 17 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: 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.

Arm	Type	Receives
Investigational Product	Experimental	Combination Product: Investigational ProductSkin will be prepared with investigational product
Reference Standard	Other	Other: Reference StandardSkin will be prepared with reference standard
Active Control	Active comparator	Combination Product: Active ComparatorSkin will be prepared with active comparator
Negative Control	Other	Other: Negative ControlSkin will be prepared with negative control

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Read, understand, and provide signed informed consent.
Are healthy subjects in good general health
Are 18 years of age or older
If females of childbearing potential, are using an acceptable form of birth control for at least 28 days immediately preceding Day 1 and throughout the duration of the study. Acceptable methods are established, effective hormonal contraception (oral/implant/injectable/transdermal/intra-vaginal), intra-uterine device [IUD], diaphragm with spermicide, condom with spermicide, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who has had a vasectomy
In the case of females of childbearing potential, have a negative urine pregnancy test (UPT) on Product Application Day prior to any applications of the study products.

Key exclusion criteria (17 listed)

Have had exposure to topical or systemic antimicrobials or any other product known to affect the normal microbial flora of the skin, antibiotics or steroids (other than hormones for contraception or post-menopausal reasons) within the product restriction period and for the remainder of the study. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, and colognes.
Subjects who have a history of skin allergies.
Have known allergies or sensitivity to vinyl, latex (rubber), alcohols, metals, inks, common consumer/beauty products, tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine, or any other product components.
Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within the product restriction period and for the remainder of the study.
Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable product application areas) within the product restriction period and for the remainder of the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Investigational Product2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation	Combination product	Investigational Product
Reference Standard60% (v/v) 1-propanol skin preparation	Other	Reference Standard
Active ComparatorChloraPrep® SEPP® skin preparation	Combination product	Active Control
Negative Control0.9% Normal Saline skin preparation	Other	Negative Control

Primary outcome

Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application
Time frame: 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.
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.
Time frame: 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.
Responder Rate at 6 Hours Post-Product Application on the Abdomen.
Time frame: 6 hours post-product application
Number of participants with bacterial reduction greater than or equal to baseline (0).
Responder Rate at 6 Hours Post-Product Application on the Groin.
Time frame: 6 hours post-product application
Number of participants with bacterial reduction greater than or equal to baseline (0).

1 secondary outcome

Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application.
Time frame: Baseline and 30 seconds post-product application

Results and safety

Results posted to the registry on 17 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	1,121	1,121

Primary outcome: Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application

Time frame: 30 seconds and 6 hours post-product application. Mean (95% Confidence Interval). Unit: Log10 CFU/cm^2

Measure	Investigational Product n = 609	Reference Standard n = 419
Abdomen 30 Seconds	2.53 (2.39 to 2.67)	2.70 (2.53 to 2.87)
Abdomen 6 hours	2.68 (2.54 to 2.82)	2.73 (2.57 to 2.89)
Groin 30 Seconds	3.69 (3.53 to 3.84)	4.07 (3.89 to 4.25)
Groin 6 hours	3.89 (3.73 to 4.04)	4.08 (3.90 to 4.27)

Population analysed: 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.

Primary outcome: Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.

Time frame: Baseline and 10 minutes post-product application. Mean (Standard Deviation). Unit: Log10 CFU/cm^2

Measure	Investigational Product n = 609	Active Control n = 609	Negative Control n = 605
Abdomen Baseline	3.93 (.61)	3.88 (.58)	4.00 (.62)
Abdomen 10 Minutes	1.34 (1.13)	1.31 (1.04)	3.19 (.80)
Groin Baseline	6.14 (.47)	6.16 (.46)	6.17 (.48)
Groin 10 Minutes	2.46 (1.36)	2.70 (1.32)	4.84 (.70)

Investigational Product vs Active Control: Mean Difference (Final Values): 0.01 (95% CI -0.15 to 0.16)
Investigational Product vs Active Control: Mean Difference (Final Values): -0.24 (95% CI -0.43 to -0.05)
Investigational Product vs Negative Control: Mean Difference (Final Values): 1.82 (95% CI 1.66 to 1.97)

Population analysed: 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.

Primary outcome: Responder Rate at 6 Hours Post-Product Application on the Abdomen.

Time frame: 6 hours post-product application. Count of participants. Unit: Participants

Measure	Investigational Product n = 291	Active Control n = 307	Negative Control n = 303
Value	286	305	265

Population analysed: 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.

Primary outcome: Responder Rate at 6 Hours Post-Product Application on the Groin.

Time frame: 6 hours post-product application. Count of participants. Unit: Participants

Measure	Investigational Product n = 295	Active Control n = 293	Negative Control n = 295
Value	295	293	291

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Product	0 of 609 (0%)	0 of 609 (0%)	0 of 609
Reference Standard	0 of 419 (0%)	0 of 419 (0%)	0 of 419
Active Control	0 of 609 (0%)	0 of 609 (0%)	0 of 609
Negative Control	0 of 605 (0%)	0 of 605 (0%)	0 of 605

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Investigational Product, Reference Standard and Active Comparator in people with Microbial Colonization, run by Becton, Dickinson and Company at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application (time frame: 30 seconds and 6 hours post-product application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04035161.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.