Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 25 |
| Updated: | 10/15/2017 |
| Start Date: | December 29, 2011 |
| End Date: | November 11, 2016 |
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
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.
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.
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive
blood culture and randomized to blinded treatment with 70% ethanol or heparin-saline placebo
catheter lock therapy.
After enrollment, all subjects will receive catheter lock therapy for a 5 day Treatment
Phase, followed by a 24 week Prophylaxis Phase. Participants in the active treatment arm will
receive 70% ethanol locks and those in the placebo arm will receive heparin-saline placebo
locks in identical fashion.
In addition to the study intervention, participants in both arms will receive standard
systemic antibiotic therapy according to the preference of the ward clinician.
The intervention will continue for 24 weeks unless off-therapy criteria are met or the
catheter is removed.
After the intervention is discontinued, participants will be monitored for 90 days, or 30
days after line removal, whichever is shorter. If the intervention is discontinued prior to
24 weeks due to adverse event or physician request, participants will be monitored for the
remainder of the 24 week period.
Primary Objective:
- To compare the proportion of therapeutic failures in children and adolescents with
CLABSI during treatment with standard care plus Ethanol Lock Therapy (ELT) versus
standard care alone.
Secondary Objectives:
- To estimate and compare the cumulative incidence of CLABSI treatment failure, relapse or
reinfection in children and adolescents receiving ELT plus standard care versus those
receiving standard care alone.
- To estimate the risk of central venous access device (CVAD) occlusion associated with
the use of ELT plus standard care, compared with standard care alone, in children and
adolescents.
- To estimate the risk of adverse events possibly attributable to ELT associated with the
use of ELT plus standard care, compared with standard care alone, in children and
adolescents.
blood culture and randomized to blinded treatment with 70% ethanol or heparin-saline placebo
catheter lock therapy.
After enrollment, all subjects will receive catheter lock therapy for a 5 day Treatment
Phase, followed by a 24 week Prophylaxis Phase. Participants in the active treatment arm will
receive 70% ethanol locks and those in the placebo arm will receive heparin-saline placebo
locks in identical fashion.
In addition to the study intervention, participants in both arms will receive standard
systemic antibiotic therapy according to the preference of the ward clinician.
The intervention will continue for 24 weeks unless off-therapy criteria are met or the
catheter is removed.
After the intervention is discontinued, participants will be monitored for 90 days, or 30
days after line removal, whichever is shorter. If the intervention is discontinued prior to
24 weeks due to adverse event or physician request, participants will be monitored for the
remainder of the 24 week period.
Primary Objective:
- To compare the proportion of therapeutic failures in children and adolescents with
CLABSI during treatment with standard care plus Ethanol Lock Therapy (ELT) versus
standard care alone.
Secondary Objectives:
- To estimate and compare the cumulative incidence of CLABSI treatment failure, relapse or
reinfection in children and adolescents receiving ELT plus standard care versus those
receiving standard care alone.
- To estimate the risk of central venous access device (CVAD) occlusion associated with
the use of ELT plus standard care, compared with standard care alone, in children and
adolescents.
- To estimate the risk of adverse events possibly attributable to ELT associated with the
use of ELT plus standard care, compared with standard care alone, in children and
adolescents.
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.
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
We found this trial at
2
sites
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Joshua Wolf, MBBS, BA
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
Click here to add this to my saved trials
Parkville, Victoria
Principal Investigator: Tom Connell, FRACP, PhD
Phone: 61 3 9345 4859
Click here to add this to my saved trials