NCT02255318

Brief Summary

The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. The rate of mortality from these infections is about 17%. The objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral nutrition. This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive pressure). The lock will be instilled after the end of the session IV treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary endpoint will be the rate IRCIC in both groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

September 30, 2014

Last Update Submit

October 27, 2016

Conditions

CancerInfection

Keywords

Taurolock®infections related to chambers implantable catheterpatients with cancer receiving parenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush.

    Definition of IRCIC This definition of infections related to chamber implantable catheters will be used for all patients. It is based on the identification of the same germ blood cultures of peripheral vein and those of the central venous line with a differential time greater than 120 minutes growth.

    The incidence will be assessed between the inclusion and 3 months after the beginning of the study.

Secondary Outcomes (2)

  • Delay onset of IRCIC

    between the inclusion and 3 months after the beginning of the study

  • Duration of hospitalizations for IRCIC.

    between the inclusion and 3 months after the beginning of the study

Study Arms (2)

Taurolock

EXPERIMENTAL

Patients received Taurolock lock for 3 months administration.

Device: Taurolock

Placebo

PLACEBO COMPARATOR

Patients received placebo lock (physiological serum) for 3 months administration.

Drug: Placebo

Interventions

TaurolockDEVICE
Taurolock
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years and over
  • Patients with solid cancer
  • Patients with implantable catheter
  • Patients receiving parenteral nutrition
  • Patient affiliated to a social security scheme or beneficiary of such a regime

You may not qualify if:

  • Patients refusing to participate in the protocol
  • Patients already receiving preventive lock of IRCIC
  • Known citrate or (cyclo) allergy -taurolidine
  • Patients taking other drugs with known contraindications against the citrate or cyclotaurolidine.
  • Participation in another protocol for the prevention of infections associated with central venous catheters
  • Patients who did not sign the consent
  • Patient with a status of socio-legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Edouard Herriot

France, Lyon, 69003, France

RECRUITING

Hôpital de la Croix Rousse

France, France

RECRUITING

Groupement Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsInfections

Study Officials

  • Cécile CHAMBRIER, PH

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile CHAMBRIER, PH

CONTACT

4.72 00 15 25cecile.chambrier@chu-lyon.fr

Isabelle DELFOUR

CONTACT

4.26.73.27.25isabelle.delfour@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 2, 2014

Study Start

January 1, 2015

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

FR(3)