Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients (COAT)
Primary Purpose
Bloodstream Infection
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Sponsored by
About this trial
This is an interventional prevention trial for Bloodstream Infection focused on measuring neutropenia, cancer, fever, central venous catheter, infection
Eligibility 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
Sites / Locations
- Klinikum Schwabing
- Klinikum Neuperlach
- Universitätsklinikum Aachen
- University Hospital Cologne
- Universitätsmedizin Berlin - Charité
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
3M™ Tegaderm CHG IV
3M™ Tegaderm™ Advanced IV'
Arm Description
Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.
Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Outcomes
Primary Outcome Measures
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
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
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
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
Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)
Overall catheter-related bloodstream infection-related severe sepsis
Overall catheter-related bloodstream infection-related severe sepsis (evaluated by definite, probable and proven criteria)
Overall catheter-related bloodstream infection-related mortality
Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)
Overall mortality
Overall mortality
Time to removal of central venous catheter
Time to removal of central venous catheter
Time to central venous catheter-related blood stream infections
Time to central venous catheter-related blood stream infections
Time to first neutropenic fever
Time to first neutropenic fever
Rate of unplanned changes
Rate of unplanned changes of the catheter securement dressing.
Tolerability/safety
Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.
Full Information
NCT ID
NCT01544686
First Posted
February 22, 2012
Last Updated
December 8, 2015
Sponsor
University of Cologne
Collaborators
3M
1. Study Identification
Unique Protocol Identification Number
NCT01544686
Brief Title
Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients
Acronym
COAT
Official Title
Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
Collaborators
3M
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. CHG iv Tegaderm securement dressing will be randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bloodstream Infection
Keywords
neutropenia, cancer, fever, central venous catheter, infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
630 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3M™ Tegaderm CHG IV
Arm Type
Active Comparator
Arm Description
Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.
Arm Title
3M™ Tegaderm™ Advanced IV'
Arm Type
Placebo Comparator
Arm Description
Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Intervention Type
Device
Intervention Name(s)
3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Intervention Description
Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Primary Outcome Measure Information:
Title
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
Description
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter
Description
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
Title
Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
Description
Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
Time Frame
14 days
Title
Overall incidence of catheter-related bloodstream infection
Description
Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)
Time Frame
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Title
Overall catheter-related bloodstream infection-related severe sepsis
Description
Overall catheter-related bloodstream infection-related severe sepsis (evaluated by definite, probable and proven criteria)
Time Frame
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Title
Overall catheter-related bloodstream infection-related mortality
Description
Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)
Time Frame
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Title
Overall mortality
Description
Overall mortality
Time Frame
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Title
Time to removal of central venous catheter
Description
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
Title
Time to central venous catheter-related blood stream infections
Description
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
Title
Time to first neutropenic fever
Description
Time to first neutropenic fever
Time Frame
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Title
Rate of unplanned changes
Description
Rate of unplanned changes of the catheter securement dressing.
Time Frame
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Title
Tolerability/safety
Description
Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.
Time Frame
From placement of the central venous catheter until the follow-up at a maximum of 56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria JG Vehreschild, Dr. med.
Organizational Affiliation
University Hospital of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Schwabing
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80804
Country
Germany
Facility Name
Klinikum Neuperlach
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81737
Country
Germany
Facility Name
Universitätsklinikum Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
Facility Name
University Hospital Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsmedizin Berlin - Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
31818338
Citation
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.
Results Reference
derived
PubMed Identifier
28514979
Citation
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.
Results Reference
derived
PubMed Identifier
27456299
Citation
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.
Results Reference
derived
Learn more about this trial
Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients
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