Infectious DiseaseEarly Phase 1Odysseus-01NCT04703335
Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309
A Early Phase 1 study testing Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparation in people with Infectious Disease, run by Zaycor Healthcare Corp.
Trial summary
A sufficient number of subjects will be entered into testing to complete 42 subjects per each of the 2 test and 2 control configurations. A total of 84 subjects, testing bi-laterally (168 abdomen and groin sites in total completed, 42 abdomen and groin sites per each test and control material) will be evaluated using… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects may be of either sex, at least 18 years of age and no more than 65 years of age, and of any race.
- Subjects must be able to read and understand English.
- Subjects must read and sign an Informed Consent Form, List of Restricted Products Form, and Allowed and Restricted Products for Hand Cleaning During Coronavirus Disease 2019 (COVID-19) Pandemic Form prior to participating in the study, as well as have an Authorization to Use and Disclose Protected Health Information Form on file at the testing facility.
- Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, asthma, lung disease, liver disease, kidney disease, heart disease, hypertension, an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated multiple sclerosis and must not have a history of smoking or vaping in the past 2 years.
- Subjects will have test sites on the skin of the abdomen and/or inguinal free of injury and in good condition (no active skin rashes, excessive freckling, moles, scratches, breaks in the skin, etc.) and have no currently active skin diseases or skin conditions (for example, contact dermatitis, psoriasis or eczema) that may compromise subject safety or study integrity.
- Subjects must have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders. Subjects with tattoos, scars, active skin rashes, or breaks in the skin of test sites, skin blemishes, such as dry scabs or warts, may be admitted at the discretion of the Principal Investigator, Subinvestigators, or Consulting Physicians.
- Subjects must be able to lay on their backs with one leg bent to expose inguinal test site for approximately 20 minutes
Who cannot join
- Known allergies to vinyl, latex (rubber), alcohols, metals, tapes or adhesives, inks, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, or to common antibacterial agents found in soaps or lotions, particularly chlorhexidine gluconate, perillyl alcohol or isopropanol.
- Have experienced hives (raised welts) as a reaction to anything that contacted the skin with the exception of items that cause hives as a reaction to the general population (e.g. poison oak and poison ivy).
- Use of systemic or topical antibiotic medications.
- Use of systemic or topical steroids, other than for contraception, hormone therapy, post-menopausal indications. This includes steroid medications used to treat asthma. Note: topically applied hormonal steroids used for post-menopausal reasons must not get on the test sites.
- Any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).
- Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test period of the study, or nursing a child. Female subjects must have a negative urine pregnancy test documented before treatment with test materials.
- Current participation or participation in a clinical study in the 14 days prior to the first lab visit.
- Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physicians, would preclude participation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309 With Controls When Used as a Preoperative Skin Disinfection Preparation.
A sufficient number of subjects will be entered into testing to complete 42 subjects per each of the 2 test and 2 control configurations. A total of 84 subjects, testing bi-laterally (168 abdomen and groin sites in total completed, 42 abdomen and groin sites per each test and control material) will be evaluated using the standardized ASTM E1173 test method. Following a 14-day restriction period, subjects will be sampled for baseline, 10 minutes, 6 hours, and 24 hours post application (subjects will not be sequestered) for microbial reduction evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and groin: ≥ 5.0 log10 CFU/cm2.
Read the detailed description
At least 84 subjects will be treated bilaterally with two of the four test materials (Test Product #1, Test Product #2, Positive Control, and Negative Control), one per each side of the abdomen and inguinal test sites. Subjects will be required to complete a 14-day pretest conditioning period. Subjects will complete a 2-day test period, during which time subjects' sites will be treated with the test materials and samples taken following treatment. The Cylinder Sampling Technique will be performed for baseline and for sampling 10-minutes, 6-hours, and 24-hours post-test material-application on Test Days.
The effectiveness criteria are that the log10 recoveries of the two test products (1% and 1.5%) are non-inferior to the Positive Control (2.0% chlorhexidine gluconate) with a 0.5 margin (log10 scale) per square centimeter on the abdominal and inguinal sites within 10 minutes after drying. The determination of non-inferiority will be based on the upper bounds of the 95% confidence interval being equal to or less than 0.5. Superiority will not be evaluated in this study.
- Conditions
- Infectious Disease
- Being tested
- Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparation
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparationDrug
Evaluate the antimicrobial efficacy of two concentrations of one patient preoperative skin preparation product compared to a positive control (2.0% chlorhexidine gluconate) and negative control (physiological saline 0.9% solution). Following a 14-day restriction period, subjects will be sampled for baseline, 10-minutes, 6-hours, and 24-hours microbial reduction evaluations post-product application. Subjects will not be sequestered for the 6-hour or 24-hour evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and inguen: ≥ 5.0 log10 CFU/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Non-inferiority and Persistence | Experimental | Evaluate the antimicrobial efficacy of two concentrations of one patient preoperative skin preparation product compared to a positive control (2.0% chlorhexidine gluconate) and negative control (physiological saline 0.9% solution). Receives: Drug: Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial efficacy
A primary efficacy variable for this study is the immediate antimicrobial effect at 10-minutes post-application of the change on measurement of two-test products against a positive control on the skin flora. The effectiveness criteria are that the log10 recoveries of the two test products (1% and 1.5%) are non-inferior to the Positive Control (2.0% chlorhexidine gluconate) with a 0.5 margin (log10 scale) per square centimeter on the abdominal and inguinal sites within 10 minutes after drying. The determination of non-inferiority will be based on a log10 multiple linear regression model. The Average Treatment Effect (ATE) is the mean difference of the test and the positive control products used in performing a non-inferiority statistic.
Measured: 10-minutes
Secondary outcomes (1)
Persistence of Antimicrobial Effect
The log10 recoveries of the change in baseline measurements on skin flora by two test products (1% and 1.5%) must show to be superior to the Negative Control with a 1.2 margin (log10 scale) per square centimeter on the abdominal and inguinal sites within 10 minutes after drying. The determination of superiority will be based on a log10 multiple linear regression model. The Average Treatment Effect (ATE) is the mean difference of the test and the negative control products used in performing a superiority statistic.
To demonstrate persistence for the test materials, the 6-hour post-treatment measurement should be lower than or equal to the baseline measurement for 100 percent of the subjects on the abdominal and inguinal sites.
Measured: 6-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Jun 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies 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
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zaycor Healthcare Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioScience Laboratories, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703335
- Sponsor's protocol ID
- OD-01-SSI-141309
- Acronym
- Odysseus-01
- Status last verified
- Feb 2022
- First submitted
- 5 Jan 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309 With Controls When Used as a Preoperative Skin Disinfection Preparation.
- ClinicalTrials.gov ID
- NCT04703335
- Acronym / sponsor ID
- Odysseus-01 / OD-01-SSI-141309
- Conditions
- Infectious Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Zaycor Healthcare CorpIndustry (pharma, biotech, devices)
- Collaborators
- BioScience Laboratories, Inc.
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A sufficient number of subjects will be entered into testing to complete 42 subjects per each of the 2 test and 2 control configurations. A total of 84 subjects, testing bi-laterally (168 abdomen and groin sites in total completed, 42 abdomen and groin sites per each test and control material) will be evaluated using the standardized ASTM E1173 test method. Following a 14-day restriction period, subjects will be sampled for baseline, 10 minutes, 6 hours, and 24 hours post application (subjects will not be sequestered) for microbial reduction evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and groin: ≥ 5.0 log10 CFU/cm2.
Detailed description
At least 84 subjects will be treated bilaterally with two of the four test materials (Test Product #1, Test Product #2, Positive Control, and Negative Control), one per each side of the abdomen and inguinal test sites. Subjects will be required to complete a 14-day pretest conditioning period. Subjects will complete a 2-day test period, during which time subjects' sites will be treated with the test materials and samples taken following treatment. The Cylinder Sampling Technique will be performed for baseline and for sampling 10-minutes, 6-hours, and 24-hours post-test material-application on Test Days.
The effectiveness criteria are that the log10 recoveries of the two test products (1% and 1.5%) are non-inferior to the Positive Control (2.0% chlorhexidine gluconate) with a 0.5 margin (log10 scale) per square centimeter on the abdominal and inguinal sites within 10 minutes after drying. The determination of non-inferiority will be based on the upper bounds of the 95% confidence interval being equal to or less than 0.5. Superiority will not be evaluated in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-inferiority and Persistence | Experimental | Drug: Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparationEvaluate the antimicrobial efficacy of two concentrations of one patient preoperative skin preparation product compared to a positive control (2.0% chlorhexidine gluconate) and negative control (physiological saline 0.9% solution). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects may be of either sex, at least 18 years of age and no more than 65 years of age, and of any race.
- Subjects must be able to read and understand English.
- Subjects must read and sign an Informed Consent Form, List of Restricted Products Form, and Allowed and Restricted Products for Hand Cleaning During Coronavirus Disease 2019 (COVID-19) Pandemic Form prior to participating in the study, as well as have an Authorization to Use and Disclose Protected Health Information Form on file at the testing facility.
- Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, asthma, lung disease, liver disease, kidney disease, heart disease, hypertension, an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated multiple sclerosis and must not have a history of smoking or vaping in the past 2 years.
- Subjects will have test sites on the skin of the abdomen and/or inguinal free of injury and in good condition (no active skin rashes, excessive freckling, moles, scratches, breaks in the skin, etc.) and have no currently active skin diseases or skin conditions (for example, contact dermatitis, psoriasis or eczema) that may compromise subject safety or study integrity.
Key exclusion criteria (8 listed)
- Known allergies to vinyl, latex (rubber), alcohols, metals, tapes or adhesives, inks, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, or to common antibacterial agents found in soaps or lotions, particularly chlorhexidine gluconate, perillyl alcohol or isopropanol.
- Have experienced hives (raised welts) as a reaction to anything that contacted the skin with the exception of items that cause hives as a reaction to the general population (e.g. poison oak and poison ivy).
- Use of systemic or topical antibiotic medications.
- Use of systemic or topical steroids, other than for contraception, hormone therapy, post-menopausal indications. This includes steroid medications used to treat asthma. Note: topically applied hormonal steroids used for post-menopausal reasons must not get on the test sites.
- Any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).
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 |
|---|---|---|
| Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparationEvaluate the antimicrobial efficacy of two concentrations of one patient preoperative skin preparation product compared to a positive control (2.0% chlorhexidine gluconate) and negative control (physiological saline 0.9% solution). Following a 14-day restriction period, subjects will be sampled for baseline, 10-minutes, 6-hours, and 24-hours microbial reduction evaluations post-product application. Subjects will not be sequestered for the 6-hour or 24-hour evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and inguen: ≥ 5.0 log10 CFU/cm2. | Drug | Non-inferiority and Persistence |
Primary outcome
Antimicrobial efficacy
Time frame: 10-minutes
A primary efficacy variable for this study is the immediate antimicrobial effect at 10-minutes post-application of the change on measurement of two-test products against a positive control on the skin flora. The effectiveness criteria are that the log10 recoveries of the two test products (1% and 1.5%) are non-inferior to the Positive Control (2.0% chlorhexidine gluconate) with a 0.5 margin (log10 scale) per square centimeter on the abdominal and inguinal sites within 10 minutes after drying. The determination of non-inferiority will be based on a log10 multiple linear regression model. The Average Treatment Effect (ATE) is the mean difference of the test and the positive control products used in performing a non-inferiority statistic.
1 secondary outcome
Persistence of Antimicrobial Effect
Time frame: 6-hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparation in people with Infectious Disease, run by Zaycor Healthcare Corp.
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 8 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: status not confirmed, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Zayas, PhD (13058984868, jzayas@zaycor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial efficacy (time frame: 10-minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2022.