Bloodstream Infection
Conditions
Keywords
neutropenia, cancer, fever, central venous catheter, infection
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.
Interventions
DEVICE3M™ 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.
Sponsors
3M
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
| 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) |
| Overall mortality | From placement of the central venous catheter until the follow-up at a maximum of 56 days | Overall mortality |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
Countries
Germany
Outcome results
None listed