Multicenter Post Market Clinical Follow-up (PMCF) investigation to evaluate safety and effectiveness of Geistlich TauroSept® used as adjunctive treatment in patients with catheter related blood stream infection (CRBSI)
- Conditions
- Catheter related Bloodstream infection
- Registration Number
- DRKS00026042
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of infection-free catheters
- Secondary Outcome Measures
Name Time Method Different catheter complication parameters