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