Central Line-associated Bloodstream InfectionsNCT07430215
Impact of Disinfectant Caps on Nosocomial CLABSI
An observational study of Central Line-associated Bloodstream Infections, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
Trial summary
In a worldwide, one-day, prospective point-prevalence study, a prevalence of 15.1% for hospital-acquired central line-associated bloodstream infections (HA-CLABSI) was determined in 13,796 patients across 1,265 intensive care units in 75 countries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Line-associated Bloodstream Infections
- What is being tested?
- use of desinfection caps and sterile catheter cap
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient admissions to the neurological intensive care unit within one year are prospectively recruited from the patient population of the BDH Clinic in Hessisch Oldendorf. Recruitment is carried out through continuous screening of all newly admitted patients who meet the inclusion criteria. In addition, retrospective data collection is performed. Only patient data whose relatives have consented to the processing of routine data for quality assurance and research purposes are analyzed.
Who may be able to join
- Stay in the neurological intensive care unit
- Presence of a central venous catheter (CVC)
- Written consent from the legal representative of the study participant (if the participant lacks capacity to consent) and/or from the study participant (if the participant is capable of consenting) for the use of routine data for quality and research purposes
Who cannot join
- written objection to the use of routine data for quality and research purposes
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Neurehabilitative Resaerch
Hessisch Oldendorf, Lower Saxony, 31840
About this study
Official title: Incidence of Nosocomial, Catheter-associated Bloodstream Infections Depending on the Use of Disinfectant Caps
In a worldwide, one-day, prospective point-prevalence study, a prevalence of 15.1% for hospital-acquired central line-associated bloodstream infections (HA-CLABSI) was determined in 13,796 patients across 1,265 intensive care units in 75 countries. According to reference data from the National Reference Center for Surveillance of Nosocomial Infections, an average of 1.2 HA-CLABSI episodes per 1,000 central venous catheter days occurred in German intensive care units between 2020 and 2024. Since the mean length of stay for the observed patients was 4 days, this value could be significantly higher for patients with longer stays, such as those undergoing neurological rehabilitation.
Besides economic consequences (costs of CLABSI treatment, extended treatment duration), bloodstream infections also have a significant impact on treatment outcomes. Studies show that patients have twice the mortality risk after a bloodstream infection - even after adjusting for disease severity - and that bloodstream infections are associated with longer stays in the intensive care unit and in the hospital.
Read more
Bloodstream infections occur when pathogenic germs enter the bloodstream. This can happen through entry via wounds (e.g., after trauma), via venous catheters (catheter-associated), or through other infections that spread systemically (e.g., infections in the lungs, abdomen, or urinary tract).
To reduce the risk of pathogenic germs entering the bloodstream from venous catheters via the access point, disinfection caps can be used. These caps are pre-treated with 70% isopropanol and packaged sterilely. According to an observational study, the use of such disinfection caps in an oncology clinic significantly reduced the rate of contaminated blood cultures (central venous catheters) from 2.5% (17 of 692) to 0.2% (1 of 470).
To reduce the risk of pathogenic germs entering the bloodstream from venous catheters, disinfection caps can be used. As part of quality-improvement measures, the use of disinfectant caps is planned in the neurological intensive care unit. The use of these caps therefore does not constitute a study intervention in the strict sense, but rather the implementation of a new in-house quality standard.
- Being tested
- use of desinfection caps, sterile catheter cap
- Keywords
- central lien catheter, bloodstream infection, intensive care
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of desinfection capsOther
Disinfection caps are pre-disinfected closure caps for central venous catheters.
sterile catheter capOther
sterile catheter caps which has to be desinficated before using
| Study group | Role | What they receive |
|---|---|---|
| CLABSI-C | Control cohort before use of desinfection caps Receives: Other: sterile catheter cap | |
| CLABSI-T | Test cohort with use of desinfection caps Receives: Other: use of desinfection caps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CLABSI episodes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Central Line-associated Bloodstream InfectionsStudies 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
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430215
- Sponsor's protocol ID
- CLABSI
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nationales Referenzzentrum für Surveillance von nosokomialen Infektionen (NRZ) (Hrsg) (2025) KISS Krankenhaus-Infektions-Surveillance-System. Infektionssurveillance im Modul ITS-KISS. Referenzdaten. Berechnungszeitraum: Januar 2020 bis Dezember 2024
Sweet MA, Cumpston A, Briggs F, Craig M, Hamadani M. Impact of alcohol-impregnated port protectors and needleless neutral pressure connectors on central line-associated bloodstream infections and contamination of blood cultures in an inpatient oncology unit. Am J Infect Control. 2012 Dec;40(10):931-4. doi: 10.1016/j.ajic.2012.01.025. Epub 2012 May 9.
PubMed 22575286Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21.
PubMed 25331552Shannon RP, Patel B, Cummins D, Shannon AH, Ganguli G, Lu Y. Economics of central line--associated bloodstream infections. Am J Med Qual. 2006 Nov-Dec;21(6 Suppl):7S-16S. doi: 10.1177/1062860606294631.
PubMed 17077414Warren DK, Quadir WW, Hollenbeak CS, Elward AM, Cox MJ, Fraser VJ. Attributable cost of catheter-associated bloodstream infections among intensive care patients in a nonteaching hospital. Crit Care Med. 2006 Aug;34(8):2084-9. doi: 10.1097/01.CCM.0000227648.15804.2D.
PubMed 16763511Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
PubMed 19952319
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Nosocomial, Catheter-associated Bloodstream Infections Depending on the Use of Disinfectant Caps
- ClinicalTrials.gov ID
- NCT07430215
- Acronym / sponsor ID
- CLABSI
- Keywords
- central lien catheter, bloodstream infection, intensive care
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- BDH-Klinik Hessisch OldendorfUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2026 (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.
In a worldwide, one-day, prospective point-prevalence study, a prevalence of 15.1% for hospital-acquired central line-associated bloodstream infections (HA-CLABSI) was determined in 13,796 patients across 1,265 intensive care units in 75 countries. According to reference data from the National Reference Center for Surveillance of Nosocomial Infections, an average of 1.2 HA-CLABSI episodes per 1,000 central venous catheter days occurred in German intensive care units between 2020 and 2024. Since the mean length of stay for the observed patients was 4 days, this value could be significantly higher for patients with longer stays, such as those undergoing neurological rehabilitation.
Besides economic consequences (costs of CLABSI treatment, extended treatment duration), bloodstream infections also have a significant impact on treatment outcomes. Studies show that patients have twice the mortality risk after a bloodstream infection - even after adjusting for disease severity - and that bloodstream infections are associated with longer stays in the intensive care unit and in the hospital.
Bloodstream infections occur when pathogenic germs enter the bloodstream. This can happen through entry via wounds (e.g., after trauma), via venous catheters (catheter-associated), or through other infections that spread systemically (e.g., infections in the lungs, abdomen, or urinary tract).
To reduce the risk of pathogenic germs entering the bloodstream from venous catheters via the access point, disinfection caps can be used. These caps are pre-treated with 70% isopropanol and packaged sterilely. According to an observational study, the use of such disinfection caps in an oncology clinic significantly reduced the rate of contaminated blood cultures (central venous catheters) from 2.5% (17 of 692) to 0.2% (1 of 470).
To reduce the risk of pathogenic germs entering the bloodstream from venous catheters, disinfection caps can be used. As part of quality-improvement measures, the use of disinfectant caps is planned in the neurological intensive care unit. The use of these caps therefore does not constitute a study intervention in the strict sense, but rather the implementation of a new in-house quality standard.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLABSI-C | – | Other: sterile catheter capControl cohort before use of desinfection caps |
| CLABSI-T | – | Other: use of desinfection capsTest cohort with use of desinfection caps |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient admissions to the neurological intensive care unit within one year are prospectively recruited from the patient population of the BDH Clinic in Hessisch Oldendorf. Recruitment is carried out through continuous screening of all newly admitted patients who meet the inclusion criteria. In addition, retrospective data collection is performed. Only patient data whose relatives have consented to the processing of routine data for quality assurance and research purposes are analyzed.
Key inclusion criteria (3 listed)
- Stay in the neurological intensive care unit
- Presence of a central venous catheter (CVC)
- Written consent from the legal representative of the study participant (if the participant lacks capacity to consent) and/or from the study participant (if the participant is capable of consenting) for the use of routine data for quality and research purposes
Key exclusion criteria (1 listed)
- written objection to the use of routine data for quality and research purposes
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 |
|---|---|---|
| use of desinfection capsDisinfection caps are pre-disinfected closure caps for central venous catheters. | Other | CLABSI-T |
| sterile catheter capsterile catheter caps which has to be desinficated before using | Other | CLABSI-C |
Primary outcome
Incidence of CLABSI episodes
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- BackgroundNationales Referenzzentrum für Surveillance von nosokomialen Infektionen (NRZ) (Hrsg) (2025) KISS Krankenhaus-Infektions-Surveillance-System. Infektionssurveillance im Modul ITS-KISS. Referenzdaten. Berechnungszeitraum: Januar 2020 bis Dezember 2024
- Background: PubMed 22575286Sweet MA, Cumpston A, Briggs F, Craig M, Hamadani M. Impact of alcohol-impregnated port protectors and needleless neutral pressure connectors on central line-associated bloodstream infections and contamination of blood cultures in an inpatient oncology unit. Am J Infect Control. 2012 Dec;40(10):931-4. doi: 10.1016/j.ajic.2012.01.025. Epub 2012 May 9.
- Background: PubMed 25331552Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21.
- Background: PubMed 17077414Shannon RP, Patel B, Cummins D, Shannon AH, Ganguli G, Lu Y. Economics of central line--associated bloodstream infections. Am J Med Qual. 2006 Nov-Dec;21(6 Suppl):7S-16S. doi: 10.1177/1062860606294631.
- Background: PubMed 16763511Warren DK, Quadir WW, Hollenbeak CS, Elward AM, Cox MJ, Fraser VJ. Attributable cost of catheter-associated bloodstream infections among intensive care patients in a nonteaching hospital. Crit Care Med. 2006 Aug;34(8):2084-9. doi: 10.1097/01.CCM.0000227648.15804.2D.
- Background: PubMed 19952319Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
- 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 Central Line-associated Bloodstream Infections, run by BDH-Klinik Hessisch Oldendorf 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 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of CLABSI episodes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430215, which also lists 6 linked publications.
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 20 Apr 2026.