Overview

ATAPAC Study (TauroLock Activity in Adult Cancer Patients)

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the efficacy of a lock taurolidine-citrate solution vs standard saline solution for primary prevention of central venous catheter-associated bloodstream infection in adult patients treated with intra-venous therapy for a solid tumor
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Régional Metz-Thionville
Collaborators:
centre régional de pharmacovigilance de Nancy
Theradial
Treatments:
Citric Acid
Pharmaceutical Solutions
Taurolidine
Criteria
Inclusion Criteria:

- Patients older than 18 years

- Performance Index (WHO score) ≤ 2

- Patient with a solid cancer receiving an IV anti-tumor treatment

- Presence of a totally implantable CVC

- Anti-tumoral therapy administered by a totally implantable CVC

- Metastatic and / or (neo) adjuvant treatment

- Full hospitalised and / or day-hospital patients

- Informed written consent

- Social Health security insurance

Exclusion Criteria:

- Hematological cancer patients

- HIV-positive patients and/ or patients receiving an active immunosuppressive therapy

- Patients presenting a febrile episode within 4 days prior to randomisation

- Patients with neutropenia grade ≥ 2 (ANC ≤ 1000/mm3) on a blood testing older than 7
days

- Patients on IV antibiotic therapy

- Patients on total and / or peripheral parental nutrition

- Patients with a previous CLABSI history

- Allergy to citrate or taurolidine

- Patients who are not able to give an informed consent

- Patients under guardianship

- Patients under judicial protection

- Pregnant or breastfeeding woman