ATAPAC Study (TauroLock Activity in Adult Cancer Patients)

NCT02279121 | Completed

• 2 other identifiers: 2014-01-CHRMT2014-A01117-40
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Conditions

Catheter-Related Infections

Keywords

central venous catheter; Taurolidine; lock-therapy

Outcome Measures

Primary Outcomes (1)

• central venous catheter-associated bloodstream infection (CLABSI)

  incidence rates of CLABSI per 1000 catheter-days

  during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months

Secondary Outcomes (5)

• days of CLABSI-related hospitalisation

  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

  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

  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

  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

  during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months

Study Arms (2)

TauroLock

EXPERIMENTAL

solution of taurolidine-citrate

Device: Taurolock

Control

OTHER

saline solution

Drug: saline solution

Interventions

Taurolock DEVICE

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

Also known as: solution of taurolidine-citrate

TauroLock

saline solution DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead
• centre régional de pharmacovigilance de Nancy: collaborator
• Theradial: collaborator

Study Sites (1)

Chr Metz Thionville

Metz, 57085, France

Location

Related Publications (18)

• Quarello F, Forneris G. Prevention of hemodialysis catheter-related bloodstream infection using an antimicrobial lock. Blood Purif. 2002;20(1):87-92. doi: 10.1159/000046990.

  PMID: 11803164 BACKGROUND

• Allon M. Prophylaxis against dialysis catheter-related bacteremia with a novel antimicrobial lock solution. Clin Infect Dis. 2003 Jun 15;36(12):1539-44. doi: 10.1086/375234. Epub 2003 Jun 6.

  PMID: 12802753 BACKGROUND

• Betjes MG, van Agteren M. Prevention of dialysis catheter-related sepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial Transplant. 2004 Jun;19(6):1546-51. doi: 10.1093/ndt/gfh014. Epub 2004 Feb 19.

  PMID: 14993498 BACKGROUND

• Mandolfo S, Borlandelli S, Elli A. Catheter lock solutions: it's time for a change. J Vasc Access. 2006 Jul-Sep;7(3):99-102. doi: 10.1177/112972980600700302.

  PMID: 17019660 BACKGROUND

• Taylor C, Cahill J, Gerrish M, Little J. A new haemodialysis catheter-locking agent reduces infections in haemodialysis patients. J Ren Care. 2008 Sep;34(3):116-20. doi: 10.1111/j.1755-6686.2008.00027.x.

  PMID: 18786077 BACKGROUND

• Solomon LR, Cheesbrough JS, Ebah L, Al-Sayed T, Heap M, Millband N, Waterhouse D, Mitra S, Curry A, Saxena R, Bhat R, Schulz M, Diggle P. A randomized double-blind controlled trial of taurolidine-citrate catheter locks for the prevention of bacteremia in patients treated with hemodialysis. Am J Kidney Dis. 2010 Jun;55(6):1060-8. doi: 10.1053/j.ajkd.2009.11.025. Epub 2010 Mar 6.

  PMID: 20207458 BACKGROUND

• Filiopoulos V, Hadjiyannakos D, Koutis I, Trompouki S, Micha T, Lazarou D, Vlassopoulos D. Approaches to prolong the use of uncuffed hemodialysis catheters: results of a randomized trial. Am J Nephrol. 2011;33(3):260-8. doi: 10.1159/000324685. Epub 2011 Mar 2.

  PMID: 21372561 BACKGROUND

• Solomon LR, Cheesbrough JS, Bhargava R, Mitsides N, Heap M, Green G, Diggle P. Observational study of need for thrombolytic therapy and incidence of bacteremia using taurolidine-citrate-heparin, taurolidine-citrate and heparin catheter locks in patients treated with hemodialysis. Semin Dial. 2012 Mar-Apr;25(2):233-8. doi: 10.1111/j.1525-139X.2011.00951.x. Epub 2011 Sep 15.

  PMID: 21916999 BACKGROUND

• Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11.

  PMID: 24125729 BACKGROUND

• Toure A, Lauverjat M, Peraldi C, Boncompain-Gerard M, Gelas P, Barnoud D, Chambrier C. Taurolidine lock solution in the secondary prevention of central venous catheter-associated bloodstream infection in home parenteral nutrition patients. Clin Nutr. 2012 Aug;31(4):567-70. doi: 10.1016/j.clnu.2012.01.001. Epub 2012 Jan 28.

  PMID: 22285029 BACKGROUND

• Lebeaux D, Larroque B, Gellen-Dautremer J, Leflon-Guibout V, Dreyer C, Bialek S, Froissart A, Hentic O, Tessier C, Ruimy R, Pelletier AL, Crestani B, Fournier M, Papo T, Barry B, Zarrouk V, Fantin B. Clinical outcome after a totally implantable venous access port-related infection in cancer patients: a prospective study and review of the literature. Medicine (Baltimore). 2012 Nov;91(6):309-318. doi: 10.1097/MD.0b013e318275ffe1.

  PMID: 23117849 BACKGROUND

• Zwiech R, Adelt M, Chrul S. A Taurolidine-Citrate-Heparin Lock Solution Effectively Eradicates Pathogens From the Catheter Biofilm in Hemodialysis Patients. Am J Ther. 2016 Mar-Apr;23(2):e363-8. doi: 10.1097/MJT.0b013e31828d4610.

  PMID: 23665885 BACKGROUND

• Shah CB, Mittelman MW, Costerton JW, Parenteau S, Pelak M, Arsenault R, Mermel LA. Antimicrobial activity of a novel catheter lock solution. Antimicrob Agents Chemother. 2002 Jun;46(6):1674-9. doi: 10.1128/AAC.46.6.1674-1679.2002.

  PMID: 12019075 BACKGROUND

• Torres-Viera C, Thauvin-Eliopoulos C, Souli M, DeGirolami P, Farris MG, Wennersten CB, Sofia RD, Eliopoulos GM. Activities of taurolidine in vitro and in experimental enterococcal endocarditis. Antimicrob Agents Chemother. 2000 Jun;44(6):1720-4. doi: 10.1128/AAC.44.6.1720-1724.2000.

  PMID: 10817739 BACKGROUND

• Simon A, Ammann RA, Wiszniewsky G, Bode U, Fleischhack G, Besuden MM. Taurolidine-citrate lock solution (TauroLock) significantly reduces CVAD-associated grampositive infections in pediatric cancer patients. BMC Infect Dis. 2008 Jul 29;8:102. doi: 10.1186/1471-2334-8-102.

  PMID: 18664278 BACKGROUND

• Dumichen MJ, Seeger K, Lode HN, Kuhl JS, Ebell W, Degenhardt P, Singer M, Geffers C, Querfeld U. Randomized controlled trial of taurolidine citrate versus heparin as catheter lock solution in paediatric patients with haematological malignancies. J Hosp Infect. 2012 Apr;80(4):304-9. doi: 10.1016/j.jhin.2012.01.003. Epub 2012 Feb 18.

  PMID: 22342714 BACKGROUND

• Klek S, Szczepanek K, Hermanowicz A, Galas A. Taurolidine lock in home parenteral nutrition in adults: results from an open-label randomized controlled clinical trial. JPEN J Parenter Enteral Nutr. 2015 Mar;39(3):331-5. doi: 10.1177/0148607114525804. Epub 2014 Mar 6.

  PMID: 24604029 BACKGROUND

• Al-Amin AH, Sarveswaran J, Wood JM, Burke DA, Donnellan CF. Efficacy of taurolidine on the prevention of catheter-related bloodstream infections in patients on home parenteral nutrition. J Vasc Access. 2013 Oct-Dec;14(4):379-82. doi: 10.5301/jva.5000168. Epub 2013 Jul 1.

  PMID: 23817948 BACKGROUND

Related Links

• Prévention des infections associées aux chambres à cathéter implantables pour accès veineux. Recommandations professionnelles par consensus formalisé d'experts. Mars 2012
• Nestrigue, C., Or, Z. Surcoût des événements indésirables associés aux soins à l'hôpital. Premières estimations à partir de neuf indicateurs de sécurité des patients. Document de Travail IRDES n°44. Février 2012
• Ministère de la santé, de la jeunesse et des sports DGS/DHOS, CTINILS. Définition des infections associées aux soins (mai 2007)

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Raffaele LONGO, MD

  CHR Metz Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 30, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

FR (1)