Antimicrobial Catheter Securement Dressings for the Prevention of Central Venous Catheter-related Bloodstream Infections in Cancer Patients (COAT)
This study is currently recruiting participants.
Verified February 2012 by University of Cologne
Sponsor:
University of Cologne
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: February 28, 2012
Last verified: February 2012
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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 |
|---|---|
|
Catheter-related Bloodstream Infection |
Device: 3M Tegaderm IV securement dressing |
| 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 IV securement dressing
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: Tegaderm Advanced IV
Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
|
Device: 3M Tegaderm IV securement dressing
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544686
Contacts
| Contact: Maria JGT 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
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: | February 28, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Cologne:
|
neutropenia cancer fever central venous catheter infection |
ClinicalTrials.gov processed this record on May 23, 2013