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Bloodstream InfectionCOATNCT01544686

Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients

A study testing 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV in people with Bloodstream Infection, run by University of Cologne at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In neutropenic cancer patients, catheter-related bloodstream infections may cause severe infections and even death. To assess the prophylactic effect of a chlorhexidine coated catheter securement dressing on the incidence of catheter-related bloodstream infections, this open, randomized trial is being carried out. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bloodstream Infection
What is being tested?
3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
630 participants
Where
5 sitesGermany
Study dates
Feb 2012to Oct 2015
Phase
Interventional
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

  • Patients receiving a central venous catheter for chemotherapy of AML or ALL
  • Patients receiving a central venous catheter for high-dose chemotherapy with consecutive autologous stem cell transplantation or any other condition with an expected duration of chemotherapy-associated neutropenia of at least 5 days and an expected duration of central venous catheter use of at least 10 days
  • Age >= 18 years

Who cannot join

  • Condition with an expected duration of chemotherapy-associated neutropenia of at less than 5 days and an expected duration of central venous catheter use of less than 10 days
  • Use of a central venous catheter with antimicrobial coating other than chlorhexidine and/or silver-sulfadiazine
  • Limited venous status, impeding acquisition of peripheral blood cultures in case of febrile neutropenia
  • Patients previously enrolled in the study
  • Tunneled central venous catheters
  • Shaldon catheters
Show all 11Show fewer
  • CVC insertion via the V. femoralis
  • Fever (T > 37.8°C) related to a suspected or confirmed bacterial infection at randomization
  • Known allergic/hypersensitivity reaction to any compounds of the treatment
  • Legal incapacity or limited legal capacity
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Universitätsmedizin Berlin - Charité

    Berlin, State of Berlin, 10117

  • University Hospital Cologne

    Cologne, North Rhine-Westphalia, 50937

  • Klinikum Schwabing

    Munich, Bavaria, 80804

  • Klinikum Neuperlach

    Munich, Bavaria, 81737

Other trials in Germany

About this study

Official title: Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial

In neutropenic cancer patients, catheter-related bloodstream infections may cause severe infections and even death. To assess the prophylactic effect of a chlorhexidine coated catheter securement dressing on the incidence of catheter-related bloodstream infections, this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will be randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.

Being tested
3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Keywords
neutropenia, cancer, fever, central venous catheter, infection
Medical subject headings
Sepsis, Neutropenia, Neoplasms, Fever, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IVDevice

    Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.

Study groups in NCT01544686
Study groupRoleWhat they receive
3M™ Tegaderm CHG IVActive comparatorPatients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.
Receives: Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
3M™ Tegaderm™ Advanced IV'Placebo comparatorPatients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Receives: Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter

    Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter

    Measured: 14 days

Secondary outcomes (11)

  1. Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter

    Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter

    Measured: 14 days

  2. Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter

    Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter

    Measured: 14 days

  3. Overall incidence of catheter-related bloodstream infection

    Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

  4. Overall catheter-related bloodstream infection-related severe sepsis

    Overall catheter-related bloodstream infection-related severe sepsis (evaluated by definite, probable and proven criteria)

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

  5. Overall catheter-related bloodstream infection-related mortality

    Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

  6. Overall mortality

    Overall mortality

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

  7. Time to removal of central venous catheter

    Time to removal of central venous catheter

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

  8. Time to central venous catheter-related blood stream infections

    Time to central venous catheter-related blood stream infections

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

  9. Time to first neutropenic fever

    Time to first neutropenic fever

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

  10. Rate of unplanned changes

    Rate of unplanned changes of the catheter securement dressing.

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

  11. Tolerability/safety

    Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.

    Measured: From placement of the central venous catheter until the follow-up at a maximum of 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
None (open label)
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544686
Sponsor's protocol ID
DRKS00003368
Acronym
COAT
Status last verified
Dec 2015
First submitted
22 Feb 2012
Last updated
9 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Schalk E, Teschner D, Hentrich M, Boll B, Panse J, Schmidt-Hieber M, Vehreschild MJGT, Biehl LM. Central venous catheter-related bloodstream infections in patients with hematological malignancies: Comparison of data from a clinical registry and a randomized controlled trial. Infect Control Hosp Epidemiol. 2020 Feb;41(2):254-256. doi: 10.1017/ice.2019.335. No abstract available.

    PubMed 31818338

  • Schalk E, Biehl LM, Farber J, Schluter D, Vehreschild MJGT, Fischer T. Determination of a Cutoff Time Point for Prophylactic Exchange of Central Venous Catheters for Prevention of Central Venous Catheter-Related Bloodstream Infections in Patients with Hematological Malignancies. Infect Control Hosp Epidemiol. 2017 Jul;38(7):888-889. doi: 10.1017/ice.2017.92. Epub 2017 May 18. No abstract available.

    PubMed 28514979

  • Biehl LM, Huth A, Panse J, Kramer C, Hentrich M, Engelhardt M, Schafer-Eckart K, Kofla G, Kiehl M, Wendtner CM, Karthaus M, Ullmann AJ, Hellmich M, Christ H, Vehreschild MJ. A randomized trial on chlorhexidine dressings for the prevention of catheter-related bloodstream infections in neutropenic patients. Ann Oncol. 2016 Oct;27(10):1916-22. doi: 10.1093/annonc/mdw275. Epub 2016 Jul 25.

    PubMed 27456299

Questions about this trial

What is this clinical trial studying?

A study testing 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV in people with Bloodstream Infection, run by University of Cologne at 5 sites 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 11 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 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?

Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter (time frame: 14 days). 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 NCT01544686, which also lists 3 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 9 Dec 2015.

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