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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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ETHEL
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Central Line-Associated Bloodstream Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for \>72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The percentage of evaluable participants with therapeutic failure is reported.
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Timepoint [1]
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Up to 25 weeks after the start of treatment.
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Secondary outcome [1]
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Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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Assessment method [1]
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Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for \>72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The cumulative incidence of therapeutic failure is reported.
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Timepoint [1]
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Up to 25 weeks after the start of treatment
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Secondary outcome [2]
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Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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Assessment method [2]
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Relapse was defined as new CLABSI with an identical organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with relapse is reported.
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Timepoint [2]
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Up to 25 weeks after the start of treatment
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Secondary outcome [3]
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Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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Assessment method [3]
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Reinfection was defined as new CLABSI with a different organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with reinfection is reported.
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Timepoint [3]
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Up to 25 weeks after the start of treatment.
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Secondary outcome [4]
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Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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Assessment method [4]
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Occlusion was defined as central line occlusion or dysfunction requiring thrombolytic therapy. The percentage of evaluable participants requiring thrombolytic therapy for central line occlusion is reported.
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Timepoint [4]
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Up to 26 weeks after the start of treatment.
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Secondary outcome [5]
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Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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Assessment method [5]
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Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record. The percentage of evaluable participants with any potentially attributable adverse effect is reported.
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Timepoint [5]
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Up to 37.5 weeks after the start of treatment.
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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.
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Minimum age
6
Months
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/12/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/11/2016
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Sample size
Target
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Accrual to date
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Final
95
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital Melbourne - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Tennessee
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Funding & Sponsors
Primary sponsor type
Other
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Name
St. Jude Children's Research Hospital
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01472965
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Trial related presentations / publications
Wolf J, Connell TG, Allison KJ, Tang L, Richardson J, Branum K, Borello E, Rubnitz JE, Gaur AH, Hakim H, Su Y, Federico SM, Mechinaud F, Hayden RT, Monagle P, Worth LJ, Curtis N, Flynn PM. Treatment and secondary prophylaxis with ethanol lock therapy for central line-associated bloodstream infection in paediatric cancer: a randomised, double-blind, controlled trial. Lancet Infect Dis. 2018 Aug;18(8):854-863. doi: 10.1016/S1473-3099(18)30224-X. Epub 2018 Jun 5.
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Public notes
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Contacts
Principal investigator
Name
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Joshua Wolf, MBBS, BA
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Address
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St. Jude Children's Research Hospital
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01472965
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