NCT01186172

Brief Summary

Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.

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
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

2.5 years

First QC Date

August 17, 2010

Last Update Submit

January 4, 2012

Conditions

Bacteremia

Keywords

ethanollock therapyvascular accesscentral venous cathetersepsis

Outcome Measures

Primary Outcomes (1)

  • Ratio of saved devices

    7 days

Secondary Outcomes (4)

  • Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability

    60 days

  • Number of patients with proper parenteral therapy

    7 days

  • Ratio of saved devices

    15-30-60 days

  • Time for next bacteriemic episode

    30 days after the end of lock

Study Arms (2)

Ethanol-lock

EXPERIMENTAL

Treatment with a combination of ethanol-lock and parenteral therapy

Drug: Ethanol-lock therapy

Antibiotic lock

ACTIVE COMPARATOR

Treatment with a combination of antibiotic-lock and parenteral therapy

Drug: Antibiotic-lock

Interventions

Ethanol-lock therapyDRUG

Daily ethanol-lock with 70% ethanol instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.

Ethanol-lock
Antibiotic-lockDRUG

Daily antibiotic-lock according to 2009 IDSA Guidelines,instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.

Antibiotic lock

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: \>1 year and 10 Kgs
  • Long-term vascular device in place at least for 7 days
  • Catheter-related infection (at least presumed)
  • Will to save the infected device (expected high risk access)

You may not qualify if:

  • Known ethanol-allergy
  • Known antabuse-like drugs in use
  • Religious refusal
  • S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)
  • Tract or pocket infection
  • Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico "San Matteo"

Pavia, PV, 27100, Italy

RECRUITING

Related Publications (1)

  • Maiefski M, Rupp ME, Hermsen ED. Ethanol lock technique: review of the literature. Infect Control Hosp Epidemiol. 2009 Nov;30(11):1096-108. doi: 10.1086/606162.

    PMID: 19803767BACKGROUND

MeSH Terms

Conditions

BacteremiaSepsis

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michele Pagani, M.D.

    Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Pagani, MD

CONTACT

+390382502767m.pagani@smatteo.pv.it

Andrea Bottazzi, MD

CONTACT

+390382502767a.bottazzi@smatteo.pv.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dirigente Medico 1 livello

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 23, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

IT(1)