Status:
COMPLETED
ATAPAC Study (TauroLock Activity in Adult Cancer Patients)
Lead Sponsor:
Centre Hospitalier Régional Metz-Thionville
Collaborating Sponsors:
centre régional de pharmacovigilance de Nancy
Theradial
Conditions:
Catheter-Related Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 infecti...
Detailed Description
The central venous catheter (CVC)-associated bloodstream infection (CLABSI) represent a serious and persistent health problem in cancer patients with an implantable CVC receiving an intravenous (IV) a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT02279121
Start Date
November 1 2014
End Date
March 1 2016
Last Update
August 26 2016
Active Locations (1)
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1
Chr Metz Thionville
Metz, France, 57085