Clinical trial · Interventional
ATAPAC Study (TauroLock Activity in Adult Cancer Patients)
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
NCT02279121CI-TRIAL-00115675ATAPACcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Catheter-Related Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| saline solution | Drug | — | UNRESOLVED |
| Taurolock | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TauroLock
- description
- solution of taurolidine-citrate
- interventionNames
- Device: Taurolock
- type
- OTHER
- label
- Control
- description
- saline solution
- interventionNames
- Drug: saline solution
Primary outcomes (1)
- measure
- central venous catheter-associated bloodstream infection (CLABSI)
- timeFrame
- during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (19)
- BACKGROUNDQuarello 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
- BACKGROUNDAllon 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
- BACKGROUNDBetjes 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
- BACKGROUNDMandolfo 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
- BACKGROUNDTaylor 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
- BACKGROUNDSolomon 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
- BACKGROUNDFiliopoulos 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.