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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01472965




Registration number
NCT01472965
Ethics application status
Date submitted
14/11/2011
Date registered
17/11/2011
Date last updated
13/11/2017

Titles & IDs
Public title
Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Trial of Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line Associated Bloodstream Infection (CLABSI) in Children and Adolescents
Secondary ID [1] 0 0
ETHEL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Line-Associated Bloodstream Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ethanol
Treatment: Drugs - heparin-saline placebo

Active Comparator: Treatment - Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.

Placebo Comparator: Control - Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.


Treatment: Drugs: ethanol
70% ethanol catheter lock therapy

Treatment: Drugs: heparin-saline placebo
heparin-saline placebo catheter lock therapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Therapeutic Failures (Early or Late Failure) in Children and Adolescents With CLABSI Receiving Standard Care Plus Ethanol Lock Therapy (ELT) vs. Standard Care Alone
Timepoint [1] 0 0
Up to 25 weeks after the start of treatment.
Secondary outcome [1] 0 0
Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Timepoint [1] 0 0
Up to 25 weeks after the start of treatment
Secondary outcome [2] 0 0
Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Timepoint [2] 0 0
Up to 25 weeks after the start of treatment
Secondary outcome [3] 0 0
Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Timepoint [3] 0 0
Up to 25 weeks after the start of treatment.
Secondary outcome [4] 0 0
Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Timepoint [4] 0 0
Up to 26 weeks after the start of treatment.
Secondary outcome [5] 0 0
Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Timepoint [5] 0 0
Up to 37.5 weeks after the start of treatment.

Eligibility
Key inclusion criteria
- Subjects =6 months to < 25 years of age who are =5kg

- New diagnosis (within 96 hours of collection of first positive blood culture) of
CLABSI (participants with previous CLABSI will be eligible if not previously enrolled
in the study)

- Silicone CVAD in situ (ports, Hickman and Broviac lines will all be eligible)

- Treating clinician plans to attempt salvage of CVAD

- Participant is receiving treatment for cancer or any hematologic disorder or is
receiving hematopoietic stem cell transplantation (HSCT) at a participating
institution.
Minimum age
6 Months
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Allergy to ethanol or components of placebo lock

- Concomitant use of metronidazole, disulfiram or trabectedin

- Plan to remove CVAD within 6 days

- Continuous use of all lumens of CVAD leading to anticipated inability to lock each
lumen for at least 2 hours per day

- Known CVAD obstruction

- Subjects who are capable of becoming pregnant will require an negative pregnancy test
before entry to study

- Use of ELT in the preceding 2 weeks

- Expected survival <6 days

- Proven alternative source of bloodstream infection (BSI), or clinical evidence of CVAD
track or port-pocket infection

- Multiple long-term CVADs in situ

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/11/2016
Sample size
Target
Accrual to date
Final
95
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Other
Name
St. Jude Children's Research Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Use of long-term central venous access devices (including tunneled lines and ports) can be
associated with development of bloodstream infection caused by build-up of bacteria or fungus
on the inside of the device, called central line associated bloodstream infection (CLABSI).
This infection generally requires hospital admission and antibiotic therapy. This treatment
usually helps eradicate the infection but sometimes it is not possible to clear or it comes
back after treatment. Also, once someone has had one line infection the chance of getting
another one is higher. This study will test whether treatment and secondary prophylaxis of
CLABSI with ethanol lock therapy (ELT) can significantly reduce the risk of treatment failure
(comprising failure to clear initial infection, relapse or reinfection) in children and
adolescents treated for cancer or hematologic disorders or undergoing hematopoietic stem cell
transplantation (HSCT). ELT involves injecting a solution of ethanol and water into the line
or port, allowing it to dwell for 2 hours, and then withdrawing the solution.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01472965
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joshua Wolf, MBBS, BA
Address 0 0
St. Jude Children's Research Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01472965