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Clinical investigation to evaluate safety and effectiveness of Geistlich TauroSept® used as adjunctive treatment in cancer patients with colonized or infected catheters

Clinical investigation to evaluate safety and effectiveness of Geistlich TauroSept® used as adjunctive treatment in cancer patients with colonized or infected catheters

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028535
Enrollment
25
Registered
2022-03-21
Start date
2021-05-27
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-associated infection/Catheter-associated bloodstream infection (CRBSI) Catheter dysfuntion

Interventions

Group 1: Retrospective study, data was collected from a single Italian centre for 25 patients. All patients had solid cancers of different organs and uncomplicated CRBSI verified by differential time

Sponsors

Centro di Riferimento Oncologico di Avioano (CRO)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Implanted VAD - Clinical symptoms of fever and/or chills and blood tests compatible with catheter-colonization or with uncomplicated CRBSI (increased PCT, positive blood cultures from port/and/or peripheral vein)

Exclusion criteria

Exclusion criteria: - Not provided informed consent to use clinical data for study purposes - Lack of documentation of required data in the medical records - Patients with fungal or port-pocket infections - Patients with VAD removed due to clinical instability

Design outcomes

Primary

MeasureTime frame
Catheter salvage rate after adjuvant treatment with Geistlich TauroSept®: percentage of patients with negative blood culture 48 h after treatment in relation to the total number of treated patients

Secondary

MeasureTime frame
- Incidence of catheter occlusions - Incidence of catheter-related venous thrombosis - Incidence of infectious events after treatment - Number and frequency of catheter removals due to events related to the investigational device or investigational procedure - Days of VAD permanence after use of Geistlich TauroSept® - Removal of VAD due to treatment end - Patient death - Infection-free catheter survival - Overall catheter survival (combined endpoint composed of catheter infection and occlusion)

Countries

Italy

Contacts

Public ContactFabrizio Brescia

Centro di Riferimento Oncologico di Avioano (CRO)

fabriziobrescia@gmail.com+39 0434 659111

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026