Taurolidine/Citrate Lock Therapy for Primary Prevention of Catheter-Related Infections in Cancer Patients: Results of a Prospective, Randomized, Phase IV Trial (ATAPAC)

Oncology. 2017;93(2):99-105. doi: 10.1159/000470911. Epub 2017 May 3.

Abstract

Background: Totally implantable venous access port (TIVAP)-related infections (RIs) remain a serious health problem in cancer patients receiving an intravenous (i.v.) therapy.

Patients and methods: The ATAPAC study was a prospective, randomized, monocentric, phase IV trial evaluating the efficacy of taurolidine lock solution versus standard saline solution for primary TIVAP-RI prevention in nonhematological cancer patients receiving i.v. chemotherapy. The primary endpoint was the TIVAP-RI incidence rate. From December 2014 to September 2015, 163 patients were enrolled in the study (taurolidine: n = 86 vs.

Control: n = 77). Four patients in the control group (5%) had a Staphylococcus epidermidis TIVAP-RI, and 1 patient (1%) in the taurolidine group had a Staphylococcus aureus infection. The TIVAP-RI incidence rate was 0.4 and 0.1‰ catheter-days, respectively (p = 0.21). The infection-free TIVAP survival was not statistically significant (p = 0.09). TIVAP-RI required a total of 22 hospitalization days in the taurolidine group versus 106 days in the control arm with associated costs of EUR 4,849 and EUR 36,020, respectively. Taurolidine-related toxicity was transitory and classified as grade I.

Conclusions: The ATAPAC trial did not show a significant risk-infection reduction by TauroLock™. A larger, prospective, randomized trial is needed to assess TauroLock efficacy for primary TIVAP-RI prevention in low-risk cancer patients.

Keywords: Catheter; Infection; Taurolidine; Totally implantable venous access port.

Publication types

  • Clinical Trial, Phase IV
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anti-Infective Agents / pharmacology*
  • Biofilms / drug effects*
  • Catheter-Related Infections / microbiology
  • Catheter-Related Infections / prevention & control*
  • Catheters, Indwelling / microbiology*
  • Central Venous Catheters / microbiology*
  • Female
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Neoplasms / drug therapy*
  • Primary Prevention / methods*
  • Prospective Studies
  • Taurine / analogs & derivatives*
  • Taurine / pharmacology
  • Thiadiazines / pharmacology*
  • Treatment Outcome

Substances

  • Anti-Infective Agents
  • Thiadiazines
  • Taurine
  • taurolidine