NCT02411331

Brief Summary

Implantable venous access port infections are mainly due to coagulase negative staphylococci and may be managed by antibiotic lock therapy with retention of the port. Most of the time a vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in eradicating the staphylococcal biofilm in the port. Another disadvantage of Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does not expose to the risk of emergence resistance.

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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

April 3, 2015

Last Update Submit

July 25, 2016

Conditions

Lock SolutionCatheter Related Blood Stream InfectionsCentral Venous Catheter InfectionIntravenous Drug Delivery SystemsCoagulase-negative Staphylococci Infection

Keywords

Lock SolutionCatheter related blood stream infectionsCentral venous catheter infectionIntravenous Drug Delivery SystemsCoagulase-negative staphylococci infectionEthanol lock solutionVancomycin lock solution

Outcome Measures

Primary Outcomes (3)

  • Recovery at 12 week following the lock solution treatment completion

    at 12 week

  • Favorable evolution without complication up to the end of implantable venous access port use

    at 12 week

  • Favorable evolution without complication until the implantable venous access port withdrawal

    at 12 week

Secondary Outcomes (6)

  • Negative peripheral and port blood cultures

    at day 3 and day 10

  • Mortality due to infection of the port

    at day 1

  • Implantable venous access port withdrawal rate

    at day 1

  • Mechanical complication rate

    at day 1

  • Blood alcohol concentration

    30 min after the first lock solution treatment

  • +1 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

90 patients will receive 10 injections of ethanol lock solution in implantable venous access port during the first 10 days of the study.

Drug: Ethanol 40% + Enoxaparine 400UI/ml

control group

OTHER

90 patients will receive 10 injections of vancomycin lock solution in implantable venous access port during the first 10 days of the study

Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml

Interventions

Ethanol 40% + Enoxaparine 400UI/mlDRUG
Experimental group
Vancomycine 5 mg/ml + Héparine 2500UI/mlDRUG
control group

Eligibility Criteria

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

You may qualify if:

  • Man or woman from 18 years old
  • With probable or definite implantable venous access port infection
  • With or without bacteraemia
  • Infection due to coagulase-negative staphylococci (except for lugdunensis Staphylococci)
  • With health insurance

You may not qualify if:

  • Pregnant or breastfeeding woman
  • Allergy to ethanol
  • Patient with prosthetic cardiac valve
  • Necessity of venous access port withdrawal
  • Prior infection on the same venous access port
  • Patients under supervision or (legal) guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Interventions

EthanolEnoxaparinVancomycin

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHeparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydratesGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Olivier LESENS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 8, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

FR(1)