Clinical Trial: ATAPAC Study (TauroLock Activity in Adult Cancer Patients)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective, Randomized, Controlled Trial Evaluating the Efficacy of a Lock-therapy With a Solution of Taurolidine/Citrate (TauroLock) vs Standard Saline Solution for the Primary Prevention of
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 infection in adult patients treated with intra-venous therapy for a solid tumor
Detailed Summary:
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) anti-tumor therapy. The CLABSI include the CVC-associated bacteremia and the negative bloodstream local or generalized infections. CLABSI significantly increase morbidity and hospital costs. They can lead also to discontinuation of IV anti-tumor treatment, a severe sepsis, a septic shock or a death. Microbial colonization and biofilm development, which are resistant to antibiotic therapy, often lead to CVC replacement. CLABSI prevention is a key measure to improve clinical outcomes, particularly in patients at high risk. For this reason, CLABSI prevention is a national priority of the healthcare program. Taurolidine [bis-(1,1-dioxoperhydro-1,2,4-thiadiazinyl-4) methane] is an antimicrobial agent which kills and inhibits a wide range of micro-organisms in vitro, including multidrug resistant bacteria. A catheter lock solution was developed containing 1.35% taurolidine and 4% citrate. Due to the anti-adhesion activity of the taurolidine and anti-thrombotic properties of the citrate, this lock solution can disrupt bacterial adhesion to the inner surface of the implantable CVC preventing the production of biofilm. This lock solution showed a substantial reduction in the formation of biofilm and bacterial colonization of the inner surface of the implantable CVC is several prospective trials.
In a study of pediatric cancers receiving IV anti-tumor treatment, the use of a lock solution of taurolidine-citrate resulted in a reduction of Gram-positive CLABSI as compared to a control group of patients treated with a standard heparin lock solution. In another study of 71 pediatric patients, taurolidine-citrate solution reduced CLABSI compared with heparin (0.3 vs 1.3 infections per 1000 c
Sponsor: Centre Hospitalier Régional Metz-Thionville
Current Primary Outcome: central venous catheter-associated bloodstream infection (CLABSI) [ Time Frame: during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- days of CLABSI-related hospitalisation [ Time Frame: during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months ]
- Anti-tumor treatment CLABSI-related delay [ Time Frame: during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months ]
- Total CVC removal for CLABSI [ Time Frame: during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months ]
- Costs associated with the CLABSI management in the perspective of health insurance [ Time Frame: during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months ]
- Evaluation of the taurolidine-citrate solution-related adverse effects [ Time Frame: during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Régional Metz-Thionville
Dates:
Date Received: October 9, 2014
Date Started: November 2014
Date Completion:
Last Updated: August 25, 2016
Last Verified: August 2016