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Title: VO2RUNf233vrier2018.pdf Author: KARINE Created Date: 6/19/2018 8:57:55 AM.

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The central venous catheter (CVC)-associated bloodstream infection (CLABSI) represent a serious and persistent health problem in cancer patients with an implantable CVC receiving an intravenous (IV) anti-tumor therapy. The CLABSI include the CVC-associated bacteremia and the negative bloodstream local or generalized infections. CLABSI significantly increase morbidity and hospital costs. They can lead also to discontinuation of IV anti-tumor treatment, a severe sepsis, a septic shock or a death. Microbial colonization and biofilm development, which are resistant to antibiotic therapy, often lead to CVC replacement. CLABSI prevention is a key measure to improve clinical outcomes, particularly in patients at high risk. For this reason, CLABSI prevention is a national priority of the healthcare program. Taurolidine [bis-(1,1-dioxoperhydro-1,2,4-thiadiazinyl-4) methane] is an antimicrobial agent which kills and inhibits a wide range of micro-organisms in vitro, including multidrug resistant bacteria. A catheter lock solution was developed containing 1.35% taurolidine and 4% citrate. Due to the anti-adhesion activity of the taurolidine and anti-thrombotic properties of the citrate, this lock solution can disrupt bacterial adhesion to the inner surface of the implantable CVC preventing the production of biofilm. This lock solution showed a substantial reduction in the formation of biofilm and bacterial colonization of the inner surface of the implantable CVC is several prospective trials.

In a study of pediatric cancers receiving IV anti-tumor treatment, the use of a lock solution of taurolidine-citrate resulted in a reduction of Gram-positive CLABSI as compared to a control group of patients treated with a standard heparin lock solution. In another study of 71 pediatric patients, taurolidine-citrate solution reduced CLABSI compared with heparin (0.3 vs 1.3 infections per 1000 catheter-days, p: 0.03). Microbial colonization was found in 25.4% of the catheters. Regarding the toxicity, 7 patients only in the taurolidine-citrate group (20%) experienced side effects, the most being nausea, vomiting and abnormal sensations of taste.

Some clinical trials have also demonstrated the efficacy of taurolidine-citrate in terms of CLABSI reduction in patients on home total parenteral nutrition and in hemodialysis patients.

According to the French guidelines, an anti-bacterial lock therapy (preferably taurolidine) may be used as prevention in patients at increased risk of serious CLABSI complications. However, the effectiveness of the lock taurolidine-citrate solution for adult patients with solid tumors receiving an anti-tumor treatment via a totally implantable CVC is actually unknown and it remains to be assessed.

PRIMARY OBJECTIVE

- To compare the efficacy of a lock taurolidine-citrate solution vs standard saline solution for primary prevention of CLABSI in adult patients treated with IV anti-tumor therapy for a solid tumor.

SECONDARY OBJECTIVES

To compare the impact of CLABSI in the 2 groups in terms of days of hospitalisation, delay of IV anti-tumoral treatment, costs of CVC removal and CLABSI-management
To evaluate the adverse effects of the lock taurolidine-citrate solution in adult patients receiving an IV anti-tumor therapy for solid tumor PRIMARY ENDPOINT: Incidence rates of CLABSI per 1000 catheter-days

SECONDARY ENDPOINTS

Days of CLABSI-related hospitalisation
Anti-tumor treatment CLABSI-related delay
Total CVC-removal for CLABSI
Costs associated with the CLABSI management in the perspective of health insurance
Evaluation of the taurolidine-citrate solution-related adverse effects

METHODOLOGY

Single-center prospective, randomized, open-label, controlled, clinical phase IV trial
1:1 randomization

Stratification:

Metastatic vs (neo) adjuvant
Age ≤ 70 years vs > 70 years

PROCEDURES During a standard clinical visit for IV anti-tumor treatment administration, the investigator informs the patient of the study procedures and check the eligibility criteria. At the beginning of the next cure, he collects his informed consent and performs randomisation. The patient is then included in the TauroLock ™ or saline arm.

Top 10 sports documentaries. At the beginning of each course, a nurse removes the lock TauroLock ™ and / or makes rinsing the CVC. At the end of each course, she rinses again the CVC and instills TauroLock ™ solution for patients in the TauroLock ™ arm. 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: the end of the IV anti-tumor treatment, the CVC removal for mechanical reasons or a CLABSI.

A follow-up visit will be performed 7-30 days after the study end.

PATIENTS NUMBER Based on surveillance data of nosocomial infections at our institution, the incidence of CLABSI in the control group is expected to about 3 per 1000 catheter-days.

Assuming that the use of TauroLock ™ will reduce at least this rate by three (expected 1 per 1000 in the treated group rate), which is consistent with literature data, 9785 days must be followed in each group (α and β risk at 5% and 10%, respectively).

Considering a mean follow-up of 4 months, we need for 81 patients pour any treatment group, 162 patients for the 2 groups.

TRIAL TIME

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Duration of the inclusion period:

- 6 months

Duration of participation for each patient:

- Duration of IV anti-tumor treatment + 1 month of follow-up

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STATISTICAL ANALYSIS Verification

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