CLABSI - Central Line Associated Bloodstream InfectionSTERILENCT04534348
Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps
An observational study of CLABSI - Central Line Associated Bloodstream Infection and Catheter-Related Blood Stream Infection, run by University of Cologne at 1 site in Germany.
Trial summary
Observational study on the reduction of catheter-related Infections by use of self-disinfecting venous and arterial access caps (Curos caps ;3M, Saint Paul, MN, USA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLABSI - Central Line Associated Bloodstream Infection, Catheter-Related Blood Stream Infection
- What is being tested?
- 70% isopropyl alcohol-impregnated catheter caps
- Type of treatment
- Medical device
- How many people
- 598 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 31 Jan 2020
- 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: All patients treated in the hemato-oncological department at the University Clinic in Cologne, Germany, receiving a central-line catheter during one year previous to the implementation of alcohol-impregnated catheter caps as well as all patients receiving a central-line catheter during the 12 months following the implementation of CUROS were included in this study
Who may be able to join
- every patient in the hemato-oncological department who received at least one CVC was included in the study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Observational study on the reduction of catheter-related Infections by use of self-disinfecting venous and arterial access caps (Curos caps ;3M, Saint Paul, MN, USA)
- Conditions
- CLABSI - Central Line Associated Bloodstream Infection, Catheter-Related Blood Stream Infection
- Being tested
- 70% isopropyl alcohol-impregnated catheter caps
- Keywords
- CLABSI, CRBSI, Blood Stream Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% isopropyl alcohol-impregnated catheter capsDevice
Also called CUROS (3M), self disinfecting catheter caps
Implementation of 70% isopropyl alcohol-impregnated catheter caps in order to assess the number of CLABSI diagnosed during 1 Year
| Study group | Role | What they receive |
|---|---|---|
| Control | All central-line-associated blood stream infections (CLABSI) diagnosed during the year previous the implementation of 70% isopropyl alcohol-impregnated Curos catheter caps | |
| CUROS | All central-line-associated blood stream infections (CLABSI) diagnosed during the year after the implementation of 70% isopropyl alcohol-impregnated Curos catheter caps Receives: Device: 70% isopropyl alcohol-impregnated catheter caps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CLABSI
To assess the clinical efficacy of Curos in preventing CLABSI in a high-risk department (oncology and ICU)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Nov 2017
- Primary completion31 Dec 2018
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLABSI - Central Line Associated Bloodstream InfectionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria J.G.T. Vehreschild, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534348
- Sponsor's protocol ID
- STERILE
- Acronym
- STERILE
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2020
- Last updated
- 6 Apr 2025
- Results posted
- No
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps
- ClinicalTrials.gov ID
- NCT04534348
- Acronym / sponsor ID
- STERILE / STERILE
- Conditions
- CLABSI - Central Line Associated Bloodstream Infection, Catheter-Related Blood Stream Infection
- Keywords
- CLABSI, CRBSI, Blood Stream Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 1 Sep 2020 (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.
Observational study on the reduction of catheter-related Infections by use of self-disinfecting venous and arterial access caps (Curos caps ;3M, Saint Paul, MN, USA)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –All central-line-associated blood stream infections (CLABSI) diagnosed during the year previous the implementation of 70% isopropyl alcohol-impregnated Curos catheter caps |
| CUROS | – | Device: 70% isopropyl alcohol-impregnated catheter capsAll central-line-associated blood stream infections (CLABSI) diagnosed during the year after the implementation of 70% isopropyl alcohol-impregnated Curos catheter caps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated in the hemato-oncological department at the University Clinic in Cologne, Germany, receiving a central-line catheter during one year previous to the implementation of alcohol-impregnated catheter caps as well as all patients receiving a central-line catheter during the 12 months following the implementation of CUROS were included in this study
Key inclusion criteria (1 listed)
- every patient in the hemato-oncological department who received at least one CVC was included in the study
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| 70% isopropyl alcohol-impregnated catheter capsAlso: CUROS (3M), self disinfecting catheter capsImplementation of 70% isopropyl alcohol-impregnated catheter caps in order to assess the number of CLABSI diagnosed during 1 Year | Device | CUROS |
Primary outcome
Number of CLABSI
Time frame: 12 Months
To assess the clinical efficacy of Curos in preventing CLABSI in a high-risk department (oncology and ICU)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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?
An observational study of CLABSI - Central Line Associated Bloodstream Infection and Catheter-Related Blood Stream Infection, run by University of Cologne at 1 site in Germany.
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: finished, as of the sponsor's last update on 6 Apr 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 CLABSI (time frame: 12 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 6 Apr 2025.