Catheter-related Bloodstream Infection Due to Central Venous CatheterPhase 1/2NCT01301300
Evaluating Central Line Hub Contamination Using a Novel Capping Device
A Phase 1/2 study testing Disinfecting Cap in people with Catheter-related Bloodstream Infection Due to Central Venous Catheter, run by Endeavor Health at 4 sites in United States.
Trial summary
Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-related Bloodstream Infection Due to Central Venous Catheter
- What is being tested?
- Disinfecting Cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2010to Dec 2011
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled.
Who cannot join
- Minors and adult inpatients without PICCs or with PICCs for < 5 days
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
NorthShore: Evanston Hospital
Evanston, Illinois, 60201
Sue Boehm, RN, 847-926-5860, sboehm@northshore.org
Marc Wright, MS, 8475702420, mwright@northshore.org
- Recruiting
NorthShore: Glenbrook Hospital
Glenview, Illinois, 60201
Sue Boehm, RN, 847-926-5860, sboehm@northshore.org
Marc Wright, MS, 8475702420, mwright@northshore.org
- Recruiting
NorthShore: Highland Park Hospital
Highland Park, Illinois, 60201
Sue Boehm, RN, 847-926-5860, sboehm@northshore.org
Marc Wright, MS, 8475702420, mwright@northshore.org
- Recruiting
NorthShore: Skokie Hospital
Skokie, Illinois, 60201
Sue ' Boehm, RN, 847-926-5860, sboehm@northshore.org
Marc Wright, MS, 8475702420
About this study
Official title: Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device
Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. It acts as a physical barrier from touch and airborne contamination for up to 96 hours. This product has been endorsed and will be adopted for use at NorthShore University HealthSystem as a quality improvement initiative. This research study protocol is designed to confirm the anticipated benefit of this change in practice at NorthShore during the planned implementation and use.
If the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.
- Being tested
- Disinfecting Cap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disinfecting CapDevice
Also called SwabCap SC003 2000
Replace standard practice with using the disinfecting cap
| Study group | Role | What they receive |
|---|---|---|
| Glenbrook Hospital | Active comparator | Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only. Receives: Device: Disinfecting Cap |
| Evanston, Highland Park, Skokie Hospitals | Active comparator | Phase 1: Assess baseline contamination rate for patients with PICC catheters for 3-12 months.
Phase 2: Implement intervention. Assess contamination 3-12 months. Phase 3: (optional): Remove cap asses contamination rate (3-6 months) Receives: Device: Disinfecting Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml
For the research project, we will monitor the colonization of access port colonization in routine as well as SwabCap™ cared for lines as follows:
Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube.
Measured: Throughout the study with enrolled subjects (The catheter must have been in place for a period of 5 or more days before the first sample is taken.)
Secondary outcomes (1)
Central line associated bloodstream infections
Central line-associated bloodstream infections (CLABSI) as defined by the National Healthcare Safety Network (NHSN) of all patients throughout 4 hospitals in 2009-2011.
Measured: Throughout the study and from historical data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-related Bloodstream Infection Due to Central Venous CatheterStudies 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
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301300
- Sponsor's protocol ID
- EH10-125
- Status last verified
- Feb 2011
- First submitted
- 22 Feb 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device
- ClinicalTrials.gov ID
- NCT01301300
- Acronym / sponsor ID
- EH10-125
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- 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.
Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. It acts as a physical barrier from touch and airborne contamination for up to 96 hours. This product has been endorsed and will be adopted for use at NorthShore University HealthSystem as a quality improvement initiative. This research study protocol is designed to confirm the anticipated benefit of this change in practice at NorthShore during the planned implementation and use.
If the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glenbrook Hospital | Active comparator | Device: Disinfecting CapImmediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only. |
| Evanston, Highland Park, Skokie Hospitals | Active comparator | Device: Disinfecting CapPhase 1: Assess baseline contamination rate for patients with PICC catheters for 3-12 months. Phase 2: Implement intervention. Assess contamination 3-12 months. Phase 3: (optional): Remove cap asses contamination rate (3-6 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled.
Key exclusion criteria (1 listed)
- Minors and adult inpatients without PICCs or with PICCs for < 5 days
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 |
|---|---|---|
| Disinfecting CapAlso: SwabCap SC003 2000Replace standard practice with using the disinfecting cap | Device | Evanston, Highland Park, Skokie Hospitals, Glenbrook Hospital |
Primary outcome
Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml
Time frame: Throughout the study with enrolled subjects (The catheter must have been in place for a period of 5 or more days before the first sample is taken.)
For the research project, we will monitor the colonization of access port colonization in routine as well as SwabCap™ cared for lines as follows: Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube.
1 secondary outcome
Central line associated bloodstream infections
Time frame: Throughout the study and from historical data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Disinfecting Cap in people with Catheter-related Bloodstream Infection Due to Central Venous Catheter, run by Endeavor Health at 4 sites 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 1 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 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml (time frame: Throughout the study with enrolled subjects (The catheter must have been in place for a period of 5 or more days before the first sample is taken.)). 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 23 Feb 2011.