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

December 8, 2015 updated by: Maria J.G.T. Vehreschild, University of Cologne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

630

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Universitätsmedizin Berlin - Charité
    • Bavaria
      • Munich, Bavaria, Germany, 80804
        • Klinikum Schwabing
      • Munich, Bavaria, Germany, 81737
        • Klinikum Neuperlach
    • NRW
      • Aachen, NRW, Germany, 52074
        • Universitätsklinikum Aachen
      • Cologne, NRW, Germany, 50937
        • University Hospital Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
Time Frame: 14 days
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter
14 days
Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
Time Frame: 14 days
Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
14 days
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
Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)
From placement of the central venous catheter until the follow-up at a maximum of 56 days
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
Overall catheter-related bloodstream infection-related severe sepsis (evaluated by definite, probable and proven criteria)
From placement of the central venous catheter until the follow-up at a maximum of 56 days
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
Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall mortality
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall mortality
From placement of the central venous catheter until the follow-up at a maximum of 56 days
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
Time to removal of central venous catheter
From placement of the central venous catheter until the follow-up at a maximum of 56 days
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
Time to central venous catheter-related blood stream infections
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to first neutropenic fever
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to first neutropenic fever
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Rate of unplanned changes
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Rate of unplanned changes of the catheter securement dressing.
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Tolerability/safety
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.
From placement of the central venous catheter until the follow-up at a maximum of 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

3M

Investigators

  • Principal Investigator: Maria JG Vehreschild, Dr. med., University Hospital of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRKS00003368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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