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ATAPAC Study (TauroLock Activity in Adult Cancer Patients) (ATAPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279121
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : August 26, 2016
Sponsor:
Collaborators:
centre régional de pharmacovigilance de Nancy
Theradial
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

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

Condition or disease Intervention/treatment Phase
Catheter-Related Infections Device: Taurolock Drug: saline solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Catheter-related Infections (CLI) in Adult Patients Wtih a Non-hematological Cancer Treated With Intravenous Anti-tumor Therapy
Study Start Date : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TauroLock
solution of taurolidine-citrate
Device: Taurolock
At the beginning of each course of IV anti-tumor treatment, a nurse removes the lock TauroLock ™ and makes rinsing the CVC. At the end of each course, she rinses again the CVC and instills TauroLock ™ solution. Patients will be followed for each treatment, according to the same rhythm of their anti-tumor treatment program up to the end of the study
Other Name: solution of taurolidine-citrate

Control
saline solution
Drug: saline solution
At the beginning of each course of IV anti-tumor treatment, a nurse makes rinsing the CVC. At the end of each course, she rinses again the CVC. Patients will be followed for each treatment, according to the same rhythm of their anti-tumor treatment program up to the end of the study




Primary Outcome Measures :
  1. 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 ]
    incidence rates of CLABSI per 1000 catheter-days


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279121


Locations
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France
Chr Metz Thionville
Metz, France, 57085
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
centre régional de pharmacovigilance de Nancy
Theradial
Investigators
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Principal Investigator: Raffaele LONGO, MD CHR Metz Thionville

Additional Information:
Publications:

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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT02279121    
Other Study ID Numbers: 2014-01-CHRMT
2014-A01117-40 ( Registry Identifier: ID RCB )
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Keywords provided by Centre Hospitalier Régional Metz-Thionville:
central venous catheter
Taurolidine
lock-therapy
Additional relevant MeSH terms:
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Infection
Catheter-Related Infections
Taurolidine
Citric Acid
Sodium Citrate
Pharmaceutical Solutions
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents