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

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT01544686
• Collaborator: 3M (Industry)
• Enrollment: 630
• Locations: 5
• Arms: 2
• Duration (Months): 44
• Patients Per Site: 126
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bloodstream Infection	Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 630 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

2. Definite catheter-related bloodstream infection-related mortality 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

3. Overall incidence of catheter-related bloodstream infection [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)

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

5. Overall catheter-related bloodstream infection-related mortality [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)

6. Overall mortality [From placement of the central venous catheter until the follow-up at a maximum of 56 days]

   Overall mortality

7. 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 removal of central venous catheter

8. 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 central venous catheter-related blood stream infections

9. Time to first neutropenic fever [From placement of the central venous catheter until the follow-up at a maximum of 56 days]

   Time to first neutropenic fever

10. Rate of unplanned changes [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.

11. Tolerability/safety [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Schwabing	Munich	Bavaria	Germany	80804
2	Klinikum Neuperlach	Munich	Bavaria	Germany	81737
3	Universitätsklinikum Aachen	Aachen	NRW	Germany	52074
4	University Hospital Cologne	Cologne	NRW	Germany	50937
5	Universitätsmedizin Berlin - Charité	Berlin		Germany	10117

Sponsors and Collaborators

• University of Cologne
• 3M

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria J.G.T. Vehreschild, Principal Investigator, University of Cologne
• ClinicalTrials.gov Identifier: NCT01544686
• Other Study ID Numbers: DRKS00003368
• First Posted: Mar 6, 2012
• Last Update Posted: Dec 9, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Maria J.G.T. Vehreschild, Principal Investigator, University of Cologne: neutropenia; cancer; fever; central venous catheter; infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Sepsis

Study Results

No Results Posted as of Dec 9, 2015