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

Bloodstream Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544686
• Other study ID #: DRKS00003368
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: December 8, 2015
• Start date: February 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• Infection

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen	NRW
Germany	Universitätsmedizin Berlin - Charité	Berlin
Germany	University Hospital Cologne	Cologne	NRW
Germany	Klinikum Neuperlach	Munich	Bavaria
Germany	Klinikum Schwabing	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	3M

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14 days	No
Secondary	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	14 days	No
Secondary	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	14 days	No
Secondary	Overall incidence of catheter-related bloodstream infection	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	No
Secondary	Overall catheter-related bloodstream infection-related severe sepsis	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	No
Secondary	Overall catheter-related bloodstream infection-related mortality	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	No
Secondary	Overall mortality	Overall mortality	From placement of the central venous catheter until the follow-up at a maximum of 56 days	No
Secondary	Time to removal of central venous catheter	Time to removal of central venous catheter	From placement of the central venous catheter until the follow-up at a maximum of 56 days	No
Secondary	Time to central venous catheter-related blood stream infections	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	No
Secondary	Time to first neutropenic fever	Time to first neutropenic fever	From placement of the central venous catheter until the follow-up at a maximum of 56 days	No
Secondary	Rate of unplanned changes	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	No
Secondary	Tolerability/safety	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	Yes