Catheter-related Bloodstream InfectionNCT04822467
SQ53 Disinfectant Wipes for Prevention of CRBSI
A study testing SQ53 Wipe and Ethanol Wipe in people with Catheter-related Bloodstream Infection, run by The Cleveland Clinic at 1 site in United States.
Trial summary
SQ53 is a novel antimicrobial, sporicidal solution that is based on a platform of quaternary ammonium chloride compounds. It has been tested against a wide range of bacteria, viruses, spores and fungal pathogens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-related Bloodstream Infection
- What is being tested?
- SQ53 Wipe and Ethanol Wipe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2021to 7 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring home parenteral nutrition support via PICC line or tunneled CVC.
Who cannot join
- Age less than 18 years
- Women known to be pregnant
- Women of childbearing age who are planning a pregnancy
- Women who are breastfeeding
- Patients who will not be managed by Cleveland Clinic HPN service
- Patients who refuse to use disinfectant wipes daily.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SQ53 Disinfectant Wipes for Prevention of Catheter Related Blood Stream Infection in Patients Receiving Home Parenteral Nutrition: A Single Blind Randomized Placebo-controlled Clinical Trial
SQ53 is a novel antimicrobial, sporicidal solution that is based on a platform of quaternary ammonium chloride compounds. It has been tested against a wide range of bacteria, viruses, spores and fungal pathogens. Extensive laboratory testing has demonstrated the effectiveness of SQ53 impregnated wipes in cleaning surfaces including catheters over a 24 hour plus time period. SQ53 also received an in vitro evaluation of the irritancy potential using a tissue engineered human skin model and was found to have no potential for skin irritation. SQ53 is available as a sterilized pack with a single wipe inside. The pack is easy to open by tearing off the top end and presenting the contents to the operator to remove under sterile conditions.
The current study will be a randomized single-blinded placebo-controlled clinical trial for SQ53 wipes intended for catheter cleaning in patients receiving home parenteral nutrition.
Read the detailed description
Parenteral nutrition (PN) therapy is an essential component of medical management of patients suffering from intestinal failure. Depending on the underlying etiology and the type of intestinal failure, the duration of parenteral nutrition therapy could range from several weeks to several years, although a substantial proportion of these patients also require lifelong parenteral nutrition support. These patients continue the infusion of PN at their homes and are managed by the Cleveland Clinic's Home PN support team. These patients require Central Venous Catheters (CVC) for prolonged period of time for infusion of parenteral nutrition. The two most commonly used central catheters for TPN infusion are the Peripherally Inserted Central Catheter (PICC) and Tunneled CVCs. Catheter related blood stream infection (CRBSI) is a major complication of long-term CVCs. CRBSI is associated with high morbidity, mortality and healthcare cost. Additionally, CRBSI can also lead to an interruption in nutrient delivery, loss of work and productivity, premature vascular access device removal, and poor quality of life.
Prevention of CRBSI is an important component of clinical management of patients receiving home PN therapy. Several strategies have been adopted to reduce the incidence of CRBSI. A heparin lock solution was used in the past for many years; however, current nutrition society guidelines recommend normal saline locks instead of heparin locks. Published data has suggested that heparin locks have not proven to have a substantial effect on CRBSI prevention, and it paradoxically increases the infection risk due to biofilm production. Antibiotic locks have also been used, although this practice is largely not preferred due to increased risk of infections with resistant microorganisms. Taurolidine is another lock solution which has been studied in the countries outside the United States such as Canada; however, it has not been approved for the use in the U.S. yet.1
- Conditions
- Catheter-related Bloodstream Infection
- Being tested
- SQ53 Wipe, Ethanol Wipe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQ53 WipeDevice
SQ53-based wipe to be used by the participant daily or upon dressing change
Ethanol WipeDevice
Ethanol-based wipe to be used by the participant daily or upon dressing change
| Study group | Role | What they receive |
|---|---|---|
| Standard Wipe | Active comparator | Participants will receive a supply of ethanol-based wipes for daily use Receives: Device: Ethanol Wipe |
| SQ53 Wipe | Experimental | Participants will receive a supply of SQ53 wipes for daily use. Receives: Device: SQ53 Wipe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months
Reduction in the number of CRBSI experienced by participants over a six month period (1000 days)
Measured: 6 months
Secondary outcomes (1)
Catheter Exchange Rates
Reduction in catheter exchange rates by participants over 1000 days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start10 Dec 2021
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
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 Catheter-related Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- JVS Products, Ltd.
- Responsible party
- Principal investigator, Donald Kirby, The Cleveland Clinic
- Investigators
- Donald Kirby, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822467
- Sponsor's protocol ID
- CC-SQ53
- Status last verified
- May 2023
- First submitted
- 26 Mar 2021
- Last updated
- 2 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SQ53 Disinfectant Wipes for Prevention of Catheter Related Blood Stream Infection in Patients Receiving Home Parenteral Nutrition: A Single Blind Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04822467
- Acronym / sponsor ID
- CC-SQ53
- Conditions
- Catheter-related Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- JVS Products, Ltd.
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Posted 2 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SQ53 is a novel antimicrobial, sporicidal solution that is based on a platform of quaternary ammonium chloride compounds. It has been tested against a wide range of bacteria, viruses, spores and fungal pathogens. Extensive laboratory testing has demonstrated the effectiveness of SQ53 impregnated wipes in cleaning surfaces including catheters over a 24 hour plus time period. SQ53 also received an in vitro evaluation of the irritancy potential using a tissue engineered human skin model and was found to have no potential for skin irritation. SQ53 is available as a sterilized pack with a single wipe inside. The pack is easy to open by tearing off the top end and presenting the contents to the operator to remove under sterile conditions.
The current study will be a randomized single-blinded placebo-controlled clinical trial for SQ53 wipes intended for catheter cleaning in patients receiving home parenteral nutrition.
Detailed description
Parenteral nutrition (PN) therapy is an essential component of medical management of patients suffering from intestinal failure. Depending on the underlying etiology and the type of intestinal failure, the duration of parenteral nutrition therapy could range from several weeks to several years, although a substantial proportion of these patients also require lifelong parenteral nutrition support. These patients continue the infusion of PN at their homes and are managed by the Cleveland Clinic's Home PN support team. These patients require Central Venous Catheters (CVC) for prolonged period of time for infusion of parenteral nutrition. The two most commonly used central catheters for TPN infusion are the Peripherally Inserted Central Catheter (PICC) and Tunneled CVCs. Catheter related blood stream infection (CRBSI) is a major complication of long-term CVCs. CRBSI is associated with high morbidity, mortality and healthcare cost. Additionally, CRBSI can also lead to an interruption in nutrient delivery, loss of work and productivity, premature vascular access device removal, and poor quality of life.
Prevention of CRBSI is an important component of clinical management of patients receiving home PN therapy. Several strategies have been adopted to reduce the incidence of CRBSI. A heparin lock solution was used in the past for many years; however, current nutrition society guidelines recommend normal saline locks instead of heparin locks. Published data has suggested that heparin locks have not proven to have a substantial effect on CRBSI prevention, and it paradoxically increases the infection risk due to biofilm production. Antibiotic locks have also been used, although this practice is largely not preferred due to increased risk of infections with resistant microorganisms. Taurolidine is another lock solution which has been studied in the countries outside the United States such as Canada; however, it has not been approved for the use in the U.S. yet.1
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Wipe | Active comparator | Device: Ethanol WipeParticipants will receive a supply of ethanol-based wipes for daily use |
| SQ53 Wipe | Experimental | Device: SQ53 WipeParticipants will receive a supply of SQ53 wipes for daily use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring home parenteral nutrition support via PICC line or tunneled CVC.
Key exclusion criteria (6 listed)
- Age less than 18 years
- Women known to be pregnant
- Women of childbearing age who are planning a pregnancy
- Women who are breastfeeding
- Patients who will not be managed by Cleveland Clinic HPN service
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 |
|---|---|---|
| SQ53 WipeSQ53-based wipe to be used by the participant daily or upon dressing change | Device | SQ53 Wipe |
| Ethanol WipeEthanol-based wipe to be used by the participant daily or upon dressing change | Device | Standard Wipe |
Primary outcome
Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months
Time frame: 6 months
Reduction in the number of CRBSI experienced by participants over a six month period (1000 days)
1 secondary outcome
Catheter Exchange Rates
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- 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.
Donald Kirby, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SQ53 Wipe and Ethanol Wipe in people with Catheter-related Bloodstream Infection, run by The Cleveland Clinic at 1 site in United States.
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 1 inclusion and 6 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 2 Jun 2023. 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 United States. 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 2 Jun 2023). 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?
Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months (time frame: 6 months). 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 2 Jun 2023.