SurgeryNCT02101762
Study to Compare CAUTI Rates Following ERASE CAUTI Tray Non-Silver vs Silver Coated Foley Catheters
An observational study of Surgery and Intensive Care Units, run by Medline Industries.
Trial summary
The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter insertion procedures using the ERASE CAUTI Tray system may help to lower these infection rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Intensive Care Units
- How many people
- 756 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Sep 2016
- Phase
- Observational
- 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
Study population: Subjects requiring urinary Foley catheters.
Who may be able to join
- At least 18 years of age
- Received Either silver coated Foley catheter or ERASE CAUTI non-silver coated catheter
Who cannot join
- UTI present upon current hospital admission
- Burn patients, transplant patients, or immune-compromised patients.
About this study
Official title: A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Non-Silver Coated Foley Catheters Verse Silver Coated Foley Catheters
The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter insertion procedures using the ERASE CAUTI Tray system may help to lower these infection rates.
- Conditions
- Surgery, Intensive Care Units
- Keywords
- Foley, Catheters, CAUTI, ERASE CAUTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Silver Coated Catheters | Subjects that had previously received silver coated Foley catheters. | |
| ERASE CAUTI Non-Silver Coated Catheters | Subjects that received non-silver catheters from an ERASE CAUTI tray. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary tract infection rates
Infection rate/1000 catheter days.
Measured: 3-9 months based on size of ICU and catheter usage
Secondary outcomes (2)
Catheter use
Number of days catheters used.
Measured: Catheter days
Infection Costs
Catheter related charges for infections
Measured: Duration of infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ed Drower, MS, Study director, Medline Industries
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101762
- Sponsor's protocol ID
- MII-001
- Status last verified
- Sep 2016
- First submitted
- 9 Feb 2012
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Non-Silver Coated Foley Catheters Verse Silver Coated Foley Catheters
- ClinicalTrials.gov ID
- NCT02101762
- Acronym / sponsor ID
- MII-001
- Conditions
- Surgery, Intensive Care Units
- Keywords
- Foley, Catheters, CAUTI, ERASE CAUTI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Apr 2014 (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.
The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter insertion procedures using the ERASE CAUTI Tray system may help to lower these infection rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Coated Catheters | – | –Subjects that had previously received silver coated Foley catheters. |
| ERASE CAUTI Non-Silver Coated Catheters | – | –Subjects that received non-silver catheters from an ERASE CAUTI tray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects requiring urinary Foley catheters.
Key inclusion criteria (2 listed)
- At least 18 years of age
- Received Either silver coated Foley catheter or ERASE CAUTI non-silver coated catheter
Key exclusion criteria (2 listed)
- UTI present upon current hospital admission
- Burn patients, transplant patients, or immune-compromised patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Urinary tract infection rates
Time frame: 3-9 months based on size of ICU and catheter usage
Infection rate/1000 catheter days.
2 secondary outcomes
Catheter use
Time frame: Catheter days
Infection Costs
Time frame: Duration of infection
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- 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.
Ed Drower, MS study director
Medline Industries
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Intensive Care Units, run by Medline Industries.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 Sep 2016. 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.
Are results available for this study?
The study was stopped early (reason given: Funding). Results are not available in the source record.
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?
Change in Urinary tract infection rates (time frame: 3-9 months based on size of ICU and catheter usage). 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 13 Sep 2016.