Clinical trial NCT01544686: Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Bloodstream Infection
Keywords: neutropenia
cancer
fever
central venous catheter
infection
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2012-03-06
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
timeFrame: 14 days
Secondary outcomes:
measure: Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter
timeFrame: 14 days
measure: Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
timeFrame: 14 days
measure: Overall incidence of catheter-related bloodstream infection
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
measure: Overall catheter-related bloodstream infection-related severe sepsis
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
measure: Overall catheter-related bloodstream infection-related mortality
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
measure: Overall mortality
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
measure: Time to removal of central venous catheter
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
measure: Time to central venous catheter-related blood stream infections
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
measure: Time to first neutropenic fever
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
measure: Rate of unplanned changes
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
measure: Tolerability/safety
timeFrame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum Schwabing
state: Bavaria
city: Munich
country: Germany
facility: Klinikum Neuperlach
state: Bavaria
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: NRW
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Charité
Study officials:
affiliation: University Hospital of Cologne
name: Maria JG Vehreschild, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.