Taurolidine/Citrate Lock Therapy for Primary Prevention of Catheter-Related Infections in Cancer Patients: Results of a Prospective, Randomized, Phase IV Trial (ATAPAC)
| Autor: | Nada Eid, Mathieu Llorens, Christian Platini, Raffaele Longo, Nadia Ouamara, Christophe Goetz, Jocelyne Sellies, Philippe Quetin |
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| Rok vydání: | 2017 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Taurine medicine.medical_treatment Phase IV Trial law.invention 03 medical and health sciences chemistry.chemical_compound Catheters Indwelling 0302 clinical medicine Anti-Infective Agents Randomized controlled trial law Neoplasms medicine Clinical endpoint Central Venous Catheters Humans Prospective Studies 030212 general & internal medicine Saline Aged Chemotherapy Thiadiazines business.industry Incidence Cancer General Medicine Middle Aged Taurolidine medicine.disease Surgery Primary Prevention Catheter Treatment Outcome Oncology chemistry Biofilms Catheter-Related Infections 030220 oncology & carcinogenesis Female business |
| Zdroj: | Oncology. 93:99-105 |
| ISSN: | 1423-0232 0030-2414 |
| DOI: | 10.1159/000470911 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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