Catheter related Bloodstream infection
Conditions
Interventions
Group 1: The infected catheter will be instilled with the catheter lock solution Geistlich TauroSept®
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age 18 years or older 3. Cancer patients having implanted central vascular access device (i.e. port-a-cath) with CRBSI 4. Estimated life expectancy of > 6 months
Exclusion criteria
Exclusion criteria: 1. Central venous access device (CVAD) exchange in the past 2. Indication for catheter removal due to technical problems, catheter dysfunction 3. Previous or current use of catheter lock solution (CLS) containing taurolidine 4. Implanted an antibiotic coated or silver impregnated central venous access device (CVAD) 5. Symptoms requiring immediate line removal at the discretion of an independent surgeon/ physician (i.e. not member of the investigational team) 6. Blood stream infection sourced by exit site infection or other than CVAD 7. Blood stream infection caused by fungi 8. History of CRBSI 9. Severe diseases (such as myocardial infarction, impaired kidney or liver function, etc.) upon decision of the investigator 10. Known allergy to taurolidine or their excipients 11. Autoimmune disease 12. Uncontrolled metabolic disease (e.g. uncontrolled diabetes) 13. Immunosuppressive therapy 14. Any clinically significant abnormalities in blood coagulation requiring intervention 15. Known or suspected noncompliance, drug or alcohol abuse 16. Inability to follow the procedures of the clinical investigation 17. Vulnerable population 18. Women of childbearing age who are not using highly effective method of birth control 19. Pregnant or breast-feeding women 20. Participation in another investigation with investigational drug, biologics or device within the 26 weeks preceding the present investigation 21. Participation in another clinical investigation during the present investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of infection-free catheters | — |
Secondary
| Measure | Time frame |
|---|---|
| Different catheter complication parameters | — |
Countries
Germany
Contacts
Public ContactDespoina Natsiou Schmiady
Geistlich Pharma AG
Outcome results
None listed