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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Cologne
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Maria J.G.T. Vehreschild, University of Cologne
ClinicalTrials.gov Identifier:
NCT01544686
First received: February 22, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Bloodstream Infection
Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter


Secondary Outcome Measures:
  • Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Incidence of definite catheter related bloodstream infection-related severe sepsis 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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter

  • Overall incidence of catheter-related bloodstream infection [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: No ]
    Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)

  • Overall catheter-related bloodstream infection-related severe sepsis [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: No ]
    Overall catheter-related bloodstream infection-related severe sepsis (evaluated by definite, probable and proven criteria)

  • Overall catheter-related bloodstream infection-related mortality [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: No ]
    Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)

  • Overall mortality [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: No ]
    Overall mortality

  • Time to removal of central venous catheter [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: No ]
    Time to removal of central venous catheter

  • Time to central venous catheter-related blood stream infections [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: No ]
    Time to central venous catheter-related blood stream infections

  • Time to first neutropenic fever [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: No ]
    Time to first neutropenic fever

  • Rate of unplanned changes [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: No ]
    Rate of unplanned changes of the catheter securement dressing.

  • Tolerability/safety [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ] [ Designated as safety issue: Yes ]
    Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.


Estimated Enrollment: 1296
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3M™ Tegaderm CHG IV
Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.
Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Placebo Comparator: 3M™ Tegaderm™ Advanced IV'
Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544686

Contacts
Contact: Maria JG Vehreschild, Dr. med. +49 221 478 ext 6494 maria.vehreschild@ctuc.de

Locations
Germany
Klinikum Neuperlach Not yet recruiting
Munich, Bavaria, Germany, 81737
Contact: Meinolf Karthaus, Prof. Dr. med.    + 49 89 6794 ext 2448    cornelia.ludwig@klinikum-muenchen.de   
Principal Investigator: Meinolf Karthaus, Prof. Dr. med.         
Klinikum Schwabing Not yet recruiting
Munich, Bavaria, Germany, 80804
Contact: Clemens Wendtner, Prof. Dr. med.    +49 89 3068 ext 3912    edith.kalff@klinikum-muenchen.de   
Principal Investigator: Clemens Wendtner, Prof. Dr. med.         
Universitätsklinikum Aachen Not yet recruiting
Aachen, NRW, Germany, 52074
Contact: Tim H Brümmendof, Prof. Dr. med.    +49 241 80 ext 89805    elucas@ukaachen.de   
Principal Investigator: Tim H Brümmendorf, Prof. Dr. med.         
University Hospital Cologne Recruiting
Cologne, NRW, Germany, 50937
Principal Investigator: Maria JGT Vehreschild, Dr. med.         
Universitätsmedizin Berlin - Charité Not yet recruiting
Berlin, Germany, 10117
Contact: Petra Gastmeier, Prof. Dr med.    +49 30 8445 ext 3680    petra.gastmeier@charite.de   
Principal Investigator: Markus Ruhnke, Prof. Dr. med.         
Sponsors and Collaborators
University of Cologne
3M
Investigators
Principal Investigator: Maria JG Vehreschild, Dr. med. University Hospital of Cologne
  More Information

No publications provided

Responsible Party: Maria J.G.T. Vehreschild, Principal Investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT01544686     History of Changes
Other Study ID Numbers: DRKS00003368
Study First Received: February 22, 2012
Last Updated: December 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
neutropenia
cancer
fever
central venous catheter
infection

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on September 22, 2014